- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00460850
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
June 27, 2008 updated by: Hoffmann-La Roche
An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c.
weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up.
The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06620
-
Antalya, Turkey, 07058
-
Istanbul, Turkey, 34390
-
Izmir, Turkey, 35360
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, 18-65 years of age;
- HBeAg negative chronic hepatitis B;
- treated with lamivudine for >=6 months;
- demonstrated lamivudine resistance;
- compensated liver disease.
Exclusion Criteria:
- severe hepatic dysfunction;
- previous treatment with antivirals other than lamivudine;
- immunosuppressant treatment in past 6 months;
- co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
- medical condition associated with chronic liver disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
180 micrograms sc weekly for 48 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time Frame: Week 96
|
Week 96
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time Frame: Weeks 48 and 72
|
Weeks 48 and 72
|
HBsAg loss and anti-HBs seroconversion
Time Frame: Weeks 48, 72 and 96
|
Weeks 48, 72 and 96
|
AEs and lab parameters
Time Frame: Throughout study
|
Throughout study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
April 16, 2007
First Submitted That Met QC Criteria
April 16, 2007
First Posted (Estimate)
April 17, 2007
Study Record Updates
Last Update Posted (Estimate)
June 30, 2008
Last Update Submitted That Met QC Criteria
June 27, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Peginterferon alfa-2a
Other Study ID Numbers
- ML20135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis B, Chronic
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Tongji HospitalGilead SciencesRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Changhai HospitalCompleted
-
Zhongshan Hospital Xiamen UniversityUnknownHealthy | Chronic Hepatitis B InfectionChina
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
-
Brii Biosciences LimitedVir Biotechnology, Inc.Active, not recruitingChronic Hepatitis B Virus InfectionSingapore, Thailand, Australia, China, Korea, Republic of
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
-
Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
Clinical Trials on peginterferon alfa-2a (40KD) [PEGASYS]
-
Baqiyatallah Medical Sciences UniversityShahid Beheshti University of Medical Sciences; Guilan University of Medical... and other collaboratorsCompletedHemophilia | Hepatitis CIran, Islamic Republic of
-
Baqiyatallah Medical Sciences UniversityGuilan University of Medical Sciences; Baqiyatallah Research Center for Gastroenterology... and other collaboratorsCompletedHepatitis C | ThalassemiaIran, Islamic Republic of
-
Hoffmann-La RocheCompletedHepatitis C, ChronicRussian Federation
-
Hoffmann-La RocheCompletedHepatitis B, ChronicRussian Federation
-
Hoffmann-La RocheCompletedHepatitis B, ChronicTaiwan, United States, New Zealand, Singapore
-
The Catholic University of KoreaUlsan University Hospital; Yonsei University; Kyungpook National University Hospital and other collaboratorsCompletedSustained Virologic Response | IL28B PolymorphismKorea, Republic of
-
Hoffmann-La RocheCompletedHepatitis B, ChronicChina, Hong Kong, Australia, Germany, Taiwan, Singapore, France, United States, Korea, Republic of, New Zealand, Thailand, Russian Federation, Brazil
-
Hoffmann-La RocheCompleted
-
Hoffmann-La RocheCompletedHepatitis B, ChronicChina, Hong Kong, Taiwan, Singapore, Korea, Republic of, New Zealand, Thailand, Brazil, Russian Federation, Australia