- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01890772
Vitamin D + Telaprevir + Peginterferon + Ribavirin for of Hepatitis C Genotype 1
A Pilot Trial of the Safety and Efficacy of Telaprevir +Peginterferon +Ribavirin +Vitamin D3 Among Treatment-naive Veterans Infected With Genotype 1 Hepatitis C Virus
This study is for people who have been diagnosed with chronic hepatitis C, specifically those who have a certain type of the virus, genotype 1, and who have not yet received treatment for hepatitis C. This pilot study is designed to test whether the addition of vitamin D, to the three drugs (Incivek (telaprevir), Pegasys (peginterferon alfa-2a), and ribavirin) that are approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C, can help eliminate the HCV from the body. Currently, doctors are unsure if the addition of vitamin D to prescribed hepatitis C therapy will have any effects on how the body clears the virus.
Once enrolled, participants will be randomly assigned (like flipping a coin) to receive telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (treatment group) or telaprevir + peginterferon alfa-2a + ribavirin (control group). A total of 80 participants, of all races/ethnicities, will be included in this study, at 5 to 10 VA hospital study sites (10 - 20 participants/site).
Participants assigned to the treatment group will begin a lead-in phase where they will receive 5,000 IU of vitamin D3 per day. Every two weeks during the lead-in phase, participants will be tested to determine the Vitamin D level in their blood, as well as other tests, including HCV RNA (to determine the amount of virus present) and calcium levels. Once an adequate level of Vitamin D is detected in participants' blood, participants will begin treatment with telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (15,000 IU/week) for 12 weeks.
Participants randomized to the control group will immediately begin treatment with telaprevir + peginterferon alfa-2a + ribavirin for 12 weeks. At the end of Week 12 the participants' involvement in the study will be complete.
Adverse events and effects of vitamin D3 will be obtained by assessing participants' medical history, physical examination, and blood tests at clinic visits. HCV RNA will be assessed at Screening, Day 1, Week 2, 4, 8 and 12.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
-
-
California
-
Long Beach, California, Verenigde Staten, 90822
- VA Long Beach Healthcare System
-
-
Minnesota
-
Minneapolis, Minnesota, Verenigde Staten, 55417
- Minneapolis VAHCS
-
-
Missouri
-
Kansas City, Missouri, Verenigde Staten, 64128
- Kansas City VA Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Philadelphia VA Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Chronic Hepatitis C genotype 1 infection
- Treatment naïve
- Age >18 years
- Agree to genetic testing
Exclusion Criteria:
- Liver disease other than from hepatitis C
- HCV infection with mixed genotypes
- Decompensated liver disease
- AFP>100ng/ml.
- Known HIV infection
- Serum 25(OH)D less than 12ng/ml or greater than 30ng/ml
- Regular vitamin D supplement use
- Regular calcium supplement use
- Refusal to abstain from vitamin D supplementation
- Current or past history of kidney stones
- Current use of any of the prohibited medications listed in section 5.5 and the INCIVEK® package insert.
- Need for therapeutic vitamin D or calcium (e.g. treatment for osteoporosis, osteomalacia, hyperparathyroidism etc.), in the opinion of the investigator
- Significant substance abuse within the past 6 months,
- Suicidal attempt in the past 10 years or suicidal ideation in past 3 months, or any other psychiatric condition that the investigator deems would make a subject unsuited for treatment with peginterferon or ribavirin.
- Confirmed or suspected malignancy, or history of malignancy within the past 3 years (except treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
- Any autoimmune disease not easily controlled (in the opinion of the investigator)
- Any condition resulting in malabsorption (
- Poorly controlled thyroid disorder, or diabetes mellitus (HbA1c > 9)
- Glomerular diseases (e.g., glomerulosclerosis or glomerulonephritis) associated with a serum creatinine >1.5 times the upper limit of normal
- Current or history of any clinically significant cardiac abnormalities/dysfunction (eg, angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension or history of use of antianginal agents for cardiac conditions (Inclusion will be considered if clearance by a cardiologist is obtained.)
- Receipt of an investigational drug within the past 30 days
- Females who have a positive pregnancy test at the time of screening, are breastfeeding or who anticipate pregnancy within the next 18 months, or men with pregnant partners
- Lack of agreement from subject to use two forms of acceptable contraception
- History or other evidence of any significant illness which, in the opinion of the investigator, would make the patient, unsuitable for the study
- Laboratory Exclusions
Hemoglobin: <12gm/dl male or female
Neutrophil: <1,200/mm3
Platelets: <90,000/mm3
INR: >1.5
Albumin: <3.2gm/dl
Total Bilirubin: >2.0mg/dl
HbA1c: >9.5%
Serum Creatinine: >1.5 times the upper limit of normal
Serum Calcium Within local laboratory normal range
Parathyroid hormone (PTH) <10 or >55 pg/mL
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: VitD+telaprevir+peginterferon+ribavirin
Participants randomized to the treatment group will receive 5,000IU/day of vitamin D3 during the lead-in phase.
When the serum 25(OH)D level is ≥35ng/ml the participant will begin telaprevir + vitamin D3 (15,000IU/week) + peginterferon alfa-2a (180ug/week) + weight based ribavirin treatment.
|
Andere namen:
Andere namen:
|
|
Actieve vergelijker: Telaprevir + Peginterferon + Ribavirin
Participants randomized to the control group immediately begin treatment with telaprevir + 180ug of peginterferon alfa-2a (Pegasys) per week and either weight based ribavirin.
|
Andere namen:
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
HCV RNA
Tijdsspanne: 4 weeks
|
Hepatitis C virus Ribonucleic Acid identifies the presence of Hepatitis C in the blood
|
4 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
adverse event profile
Tijdsspanne: 12 weeks
|
Cumulative record of unanticipated or unintended medical occurrences, not necessarily related to the study treatment.
|
12 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Timothy R Morgan, MD, Veterans Affairs Long Beach Healthcare
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Flaviviridae-infecties
- Hepatitis, viraal, menselijk
- Enterovirusinfecties
- Picornaviridae-infecties
- Hepatitis
- Hepatitis A
- Hepatitis C
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Antimetabolieten
- Micronutriënten
- Vitaminen
- Behoudsmiddelen voor botdichtheid
- Ribavirine
- Peginterferon alfa-2a
- Vitamine D
Andere studie-ID-nummers
- 1217
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Hepatitis C
-
Tripep ABInovio PharmaceuticalsOnbekendChronische hepatitis C-virusinfectieZweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsIngetrokkenChronische hepatitis C-virusinfectieIsraël
-
Hadassah Medical OrganizationOnbekendChronische hepatitis C-virusinfectieIsraël
-
Trek Therapeutics, PBCVoltooidChronische Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C virale infectieVerenigde Staten, Nieuw-Zeeland
-
Trek Therapeutics, PBCVoltooidChronische Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C virale infectieVerenigde Staten
-
AbbVieVoltooidHepatitis C-virus | Chronisch hepatitis C-virus
-
AbbVieVoltooidChronische Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
-
University Health Network, TorontoVoltooidChronische hepatitis C-infectieCanada
-
AbbVie (prior sponsor, Abbott)VoltooidChronische Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)Verenigde Staten, Australië, Canada, Frankrijk, Duitsland, Nieuw-Zeeland, Puerto Rico, Spanje, Verenigd Koninkrijk
-
Beni-Suef UniversityVoltooidChronische hepatitis C-virusinfectieEgypte
Klinische onderzoeken op Vitamine D
-
Alcon ResearchVoltooidVisieVerenigde Staten
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)VoltooidBloedarmoede van chronische nierziekteVerenigde Staten
-
Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, DenmarkVoltooidMigraine volgens de criteria van de International Headache Society (IHS) (ICHD-II)Denemarken
-
Kafrelsheikh UniversityMinistry of Health, Saudi ArabiaNog niet aan het werven
-
Rhode Island HospitalVirtually Better, Inc.VoltooidMentale gezondheid | Humaan Immunodeficiëntie VirusVerenigde Staten
-
Royal Prince Alfred Hospital, Sydney, AustraliaVoltooidColonoscopieAustralië
-
GlaxoSmithKlineVoltooidInfluenza, mensVerenigde Staten, België
-
Lee's Pharmaceutical LimitedOnbekendEierstokepitheelkanker | Eileiderkanker | Primaire buikvlieskankerChina
-
InventisBio Co., LtdWervingActieve systemische lupus erythematosusChina
-
University of AarhusNovo Nordisk A/S; Aarhus University Hospital; AP Moeller Foundation; Danish Diabetes...VoltooidVeroudering | Stoornis van het metabolisme | Ketonemie | SpierstoornisDenemarken