- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01297270
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)
A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
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Alberta
-
Calgary, Alberta, Kanada
- 1220.47.1011 Boehringer Ingelheim Investigational Site
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Edmonton, Alberta, Kanada
- 1220.47.1012 Boehringer Ingelheim Investigational Site
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British Columbia
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Vancouver, British Columbia, Kanada
- 1220.47.1001 Boehringer Ingelheim Investigational Site
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Vancouver, British Columbia, Kanada
- 1220.47.1003 Boehringer Ingelheim Investigational Site
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Vancouver, British Columbia, Kanada
- 1220.47.1016 Boehringer Ingelheim Investigational Site
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Victoria, British Columbia, Kanada
- 1220.47.1007 Boehringer Ingelheim Investigational Site
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Manitoba
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Winnipeg, Manitoba, Kanada
- 1220.47.1009 Boehringer Ingelheim Investigational Site
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Ontario
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Hamilton, Ontario, Kanada
- 1220.47.1013 Boehringer Ingelheim Investigational Site
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London, Ontario, Kanada
- 1220.47.1002 Boehringer Ingelheim Investigational Site
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Ottawa, Ontario, Kanada
- 1220.47.1004 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Kanada
- 1220.47.1005 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Kanada
- 1220.47.1006 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Kanada
- 1220.47.1015 Boehringer Ingelheim Investigational Site
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Quebec
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Montreal, Quebec, Kanada
- 1220.47.1010 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Kanada
- 1220.47.1014 Boehringer Ingelheim Investigational Site
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Pusan, Korea, Republik von
- 1220.47.8204 Boehringer Ingelheim Investigational Site
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Pusan, Korea, Republik von
- 1220.47.8205 Boehringer Ingelheim Investigational Site
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Seongnam, Korea, Republik von
- 1220.47.8203 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republik von
- 1220.47.8202 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republik von
- 1220.47.8206 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republik von
- 1220.47.8207 Boehringer Ingelheim Investigational Site
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Yangsan, Korea, Republik von
- 1220.47.8201 Boehringer Ingelheim Investigational Site
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San Juan, Puerto Rico
- 1220.47.0034 Boehringer Ingelheim Investigational Site
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Kaohsiung, Taiwan
- 1220.47.8803 Boehringer Ingelheim Investigational Site
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Kaohsiung, Taiwan
- 1220.47.8804 Boehringer Ingelheim Investigational Site
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Taichung, Taiwan
- 1220.47.8802 Boehringer Ingelheim Investigational Site
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Taipei, Taiwan
- 1220.47.8801 Boehringer Ingelheim Investigational Site
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Taipei, Taiwan
- 1220.47.8805 Boehringer Ingelheim Investigational Site
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Alabama
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Birmingham, Alabama, Vereinigte Staaten
- 1220.47.0004 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, Vereinigte Staaten
- 1220.47.0045 Boehringer Ingelheim Investigational Site
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Dothan, Alabama, Vereinigte Staaten
- 1220.47.0050 Boehringer Ingelheim Investigational Site
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Arizona
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Phoenix, Arizona, Vereinigte Staaten
- 1220.47.0061 Boehringer Ingelheim Investigational Site
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Arkansas
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North Little Rock, Arkansas, Vereinigte Staaten
- 1220.47.0091 Boehringer Ingelheim Investigational Site
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California
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Bakersfield, California, Vereinigte Staaten
- 1220.47.0008 Boehringer Ingelheim Investigational Site
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Chula Vista, California, Vereinigte Staaten
- 1220.47.0019 Boehringer Ingelheim Investigational Site
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Coronado, California, Vereinigte Staaten
- 1220.47.0010 Boehringer Ingelheim Investigational Site
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La Jolla, California, Vereinigte Staaten
- 1220.47.0033 Boehringer Ingelheim Investigational Site
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La Mesa, California, Vereinigte Staaten
- 1220.47.0035 Boehringer Ingelheim Investigational Site
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Los Angeles, California, Vereinigte Staaten
- 1220.47.0011 Boehringer Ingelheim Investigational Site
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Los Angeles, California, Vereinigte Staaten
- 1220.47.0014 Boehringer Ingelheim Investigational Site
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Los Angeles, California, Vereinigte Staaten
- 1220.47.0100 Boehringer Ingelheim Investigational Site
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Oceanside, California, Vereinigte Staaten
- 1220.47.0018 Boehringer Ingelheim Investigational Site
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Poway, California, Vereinigte Staaten
- 1220.47.0059 Boehringer Ingelheim Investigational Site
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San Diego, California, Vereinigte Staaten
- 1220.47.0024 Boehringer Ingelheim Investigational Site
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San Diego, California, Vereinigte Staaten
- 1220.47.0037 Boehringer Ingelheim Investigational Site
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San Francisco, California, Vereinigte Staaten
- 1220.47.0031 Boehringer Ingelheim Investigational Site
-
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Colorado
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Englewood, Colorado, Vereinigte Staaten
- 1220.47.0082 Boehringer Ingelheim Investigational Site
-
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten
- 1220.47.0049 Boehringer Ingelheim Investigational Site
-
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Florida
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Bradenton, Florida, Vereinigte Staaten
- 1220.47.0057 Boehringer Ingelheim Investigational Site
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Fort Lauderdale, Florida, Vereinigte Staaten
- 1220.47.0078 Boehringer Ingelheim Investigational Site
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Fort Lauderdale, Florida, Vereinigte Staaten
- 1220.47.0086 Boehringer Ingelheim Investigational Site
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Hialeah, Florida, Vereinigte Staaten
- 1220.47.0054 Boehringer Ingelheim Investigational Site
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Miami, Florida, Vereinigte Staaten
- 1220.47.0088 Boehringer Ingelheim Investigational Site
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Orlando, Florida, Vereinigte Staaten
- 1220.47.0044 Boehringer Ingelheim Investigational Site
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Orlando, Florida, Vereinigte Staaten
- 1220.47.0099 Boehringer Ingelheim Investigational Site
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Palm Harbor, Florida, Vereinigte Staaten
- 1220.47.0095 Boehringer Ingelheim Investigational Site
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Tampa, Florida, Vereinigte Staaten
- 1220.47.0074 Boehringer Ingelheim Investigational Site
-
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Georgia
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Atlanta, Georgia, Vereinigte Staaten
- 1220.47.0022 Boehringer Ingelheim Investigational Site
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Columbus, Georgia, Vereinigte Staaten
- 1220.47.0039 Boehringer Ingelheim Investigational Site
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Decatur, Georgia, Vereinigte Staaten
- 1220.47.0052 Boehringer Ingelheim Investigational Site
-
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Illinois
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Chicago, Illinois, Vereinigte Staaten
- 1220.47.0013 Boehringer Ingelheim Investigational Site
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Chicago, Illinois, Vereinigte Staaten
- 1220.47.0055 Boehringer Ingelheim Investigational Site
-
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Indiana
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Vaiparaiso, Indiana, Vereinigte Staaten
- 1220.47.0062 Boehringer Ingelheim Investigational Site
-
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Louisiana
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Baton Rouge, Louisiana, Vereinigte Staaten
- 1220.47.0085 Boehringer Ingelheim Investigational Site
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Baton Rouge, Louisiana, Vereinigte Staaten
- 1220.47.0087 Boehringer Ingelheim Investigational Site
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New Orleans, Louisiana, Vereinigte Staaten
- 1220.47.0101 Boehringer Ingelheim Investigational Site
-
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Maryland
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Baltimore, Maryland, Vereinigte Staaten
- 1220.47.0064 Boehringer Ingelheim Investigational Site
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Baltimore, Maryland, Vereinigte Staaten
- 1220.47.0069 Boehringer Ingelheim Investigational Site
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Chevy Chase, Maryland, Vereinigte Staaten
- 1220.47.0067 Boehringer Ingelheim Investigational Site
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Lutherville, Maryland, Vereinigte Staaten
- 1220.47.0079 Boehringer Ingelheim Investigational Site
-
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Massachusetts
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Framingham, Massachusetts, Vereinigte Staaten
- 1220.47.0027 Boehringer Ingelheim Investigational Site
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Springfield, Massachusetts, Vereinigte Staaten
- 1220.47.0065 Boehringer Ingelheim Investigational Site
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Mississippi
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Tulepo, Mississippi, Vereinigte Staaten
- 1220.47.0023 Boehringer Ingelheim Investigational Site
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten
- 1220.47.0046 Boehringer Ingelheim Investigational Site
-
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New Jersey
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Neptune, New Jersey, Vereinigte Staaten
- 1220.47.0066 Boehringer Ingelheim Investigational Site
-
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New York
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Bronx, New York, Vereinigte Staaten
- 1220.47.0097 Boehringer Ingelheim Investigational Site
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Brooklyn, New York, Vereinigte Staaten
- 1220.47.0083 Boehringer Ingelheim Investigational Site
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New York, New York, Vereinigte Staaten
- 1220.47.0003 Boehringer Ingelheim Investigational Site
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New York, New York, Vereinigte Staaten
- 1220.47.0006 Boehringer Ingelheim Investigational Site
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New York, New York, Vereinigte Staaten
- 1220.47.0038 Boehringer Ingelheim Investigational Site
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New York, New York, Vereinigte Staaten
- 1220.47.0090 Boehringer Ingelheim Investigational Site
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North Carolina
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Charlotte, North Carolina, Vereinigte Staaten
- 1220.47.0053 Boehringer Ingelheim Investigational Site
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Winston-Salem, North Carolina, Vereinigte Staaten
- 1220.47.0021 Boehringer Ingelheim Investigational Site
-
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Oklahoma
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Tulsa, Oklahoma, Vereinigte Staaten
- 1220.47.0098 Boehringer Ingelheim Investigational Site
-
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Oregon
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Portland, Oregon, Vereinigte Staaten
- 1220.47.0028 Boehringer Ingelheim Investigational Site
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Portland, Oregon, Vereinigte Staaten
- 1220.47.0058 Boehringer Ingelheim Investigational Site
-
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Tennessee
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Germantown, Tennessee, Vereinigte Staaten
- 1220.47.0030 Boehringer Ingelheim Investigational Site
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Jackson, Tennessee, Vereinigte Staaten
- 1220.47.0072 Boehringer Ingelheim Investigational Site
-
Nashville, Tennessee, Vereinigte Staaten
- 1220.47.0032 Boehringer Ingelheim Investigational Site
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Nashville, Tennessee, Vereinigte Staaten
- 1220.47.0041 Boehringer Ingelheim Investigational Site
-
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Texas
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Arlington, Texas, Vereinigte Staaten
- 1220.47.0063 Boehringer Ingelheim Investigational Site
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Austin, Texas, Vereinigte Staaten
- 1220.47.0029 Boehringer Ingelheim Investigational Site
-
Dallas, Texas, Vereinigte Staaten
- 1220.47.0017 Boehringer Ingelheim Investigational Site
-
Dallas, Texas, Vereinigte Staaten
- 1220.47.0056 Boehringer Ingelheim Investigational Site
-
Dallas, Texas, Vereinigte Staaten
- 1220.47.0071 Boehringer Ingelheim Investigational Site
-
Fort Worth, Texas, Vereinigte Staaten
- 1220.47.0060 Boehringer Ingelheim Investigational Site
-
Forth Worth, Texas, Vereinigte Staaten
- 1220.47.0081 Boehringer Ingelheim Investigational Site
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Houston, Texas, Vereinigte Staaten
- 1220.47.0009 Boehringer Ingelheim Investigational Site
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Houston, Texas, Vereinigte Staaten
- 1220.47.0068 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, Vereinigte Staaten
- 1220.47.0016 Boehringer Ingelheim Investigational Site
-
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Vermont
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Burlington, Vermont, Vereinigte Staaten
- 1220.47.0015 Boehringer Ingelheim Investigational Site
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Virginia
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Annandale, Virginia, Vereinigte Staaten
- 1220.47.0042 Boehringer Ingelheim Investigational Site
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Falls Church, Virginia, Vereinigte Staaten
- 1220.47.0043 Boehringer Ingelheim Investigational Site
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Richmond, Virginia, Vereinigte Staaten
- 1220.47.0026 Boehringer Ingelheim Investigational Site
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Washington
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Seattle, Washington, Vereinigte Staaten
- 1220.47.0092 Boehringer Ingelheim Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten
- 1220.47.0073 Boehringer Ingelheim Investigational Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion criteria:
Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
- positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
- liver biopsy consistent with chronic HCV infection.
- HCV genotype 1 infection confirmed by genotypic testing at screening.
- Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
- HCV RNA = 1,000 IU/mL at screening
Documentation of a liver biopsy within 3 years or fibroscan within 6 months of the screening visit.
Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not exclude patients from a trial.
- Age 18 to 70 years
Female patients:
(c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.
Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device.
Male patients:
- who are documented to be sterile, or
- who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase.
- Signed informed consent form prior to trial participation
Exclusion criteria:
- HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection.
- HIV co-infection.
- Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
- Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
- Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
- A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient¿s ability to participate in this study.
- Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study.
- Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
- Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase.
- Known hypersensitivity to any ingredient of the study drugs.
- Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).
Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following:
- International normalized ratio (INR) of =1.7
- Serum Albumin =3.5 g/dL
- Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome).
- Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: Placebo
|
|
Aktiver Komparator: PegIFN/RBV
48 weeks
|
|
Experimental: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
|
QD BI 201335
QD (once daily) BI 201335
|
Experimental: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
|
QD BI 201335
QD (once daily) BI 201335
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
|
12 weeks post treatment, up to 60 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Zeitfenster: 24 weeks post treatment, up to 72 weeks
|
Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. Hepatitis C virus Ribonucleic acid (HCV RNA) |
24 weeks post treatment, up to 72 weeks
|
Early Treatment Success (ETS)
Zeitfenster: Week 4 and week 8
|
Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.
|
Week 4 and week 8
|
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks post treatment, up to 60 weeks
|
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks post treatment, up to 60 weeks
|
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks post treatment, up to 60 weeks
|
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks post treatment, up to 60 weeks
|
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks post treatment, up to 60 weeks
|
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks post treatment, up to 60 weeks
|
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks post treatment, up to 60 weeks
|
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO
Zeitfenster: 12 weeks post treatment, up to 60 weeks
|
The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks post treatment, up to 60 weeks
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Leberkrankheiten
- Flaviviridae-Infektionen
- Hepatitis, viral, menschlich
- Enterovirus-Infektionen
- Picornaviridae-Infektionen
- Hepatitis
- Hepatitis A
- Hepatitis C
Andere Studien-ID-Nummern
- 1220.47
- 2010-021716-42 (EudraCT-Nummer: EudraCT)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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