A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)
1 other identifier
interventional
1,013
1 country
26
Brief Summary
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2008
Longer than P75 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2008
CompletedFirst Submitted
Initial submission to the registry
September 5, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2013
CompletedResults Posted
Study results publicly available
October 23, 2018
CompletedOctober 23, 2018
December 1, 2017
4.7 years
September 5, 2011
May 22, 2017
December 20, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Week 12
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Week 12
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Week 4
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
Week 4
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
Week 24
Secondary Outcomes (3)
Percentage of Participants With pEVR to Study Treatment at Week 12
Week 12
Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment
Week 12
Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24
Week 24
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, \>/= 18 years of age
- Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
- Documented pre-treatment HCV RNA quantitative result
- Compensated liver disease (Child-Pugh Grade A)
- Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
You may not qualify if:
- Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
- Co-infection with active hepatitis A and/or hepatitis B
- History or evidence of a medical condition associated with liver disease other than HCV
- Signs and symptoms of hepatocellular carcinoma
- History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
- Therapy with antineoplastic treatment \</= 6 months prior to study day
- Diabetes mellitus in subjects receiving an insulin therapy
- Evidence of severe retinopathy
- Pregnant or breast-feeding women, and male partners of women who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Haemek Hospital; Gastroenterology
Afula, 18101, Israel
Clalit City Ashdod MC; Liver Clinic
Ashdod, 77444, Israel
Barzilai MC; Gastroenterology
Ashkelon, 78278, Israel
Batyamon; Liver Unit
Bat Yam, Israel
Soroka Medical Center; Liver Unit
Beersheba, 8410101, Israel
Soroka Medical Center; Gastroenterology
Beersheba, 84105, Israel
Rambam Medical Center; Gastroenterology - Liver Unit
Haifa, 31096, Israel
Bnei-Zion Medical Center; Gastroenterology
Haifa, 33394, Israel
Carmel Hospital; Liver Unit
Haifa, 34362, Israel
Wolfson Hospital; Gastroenterology Unit
Holon, 58100, Israel
Hadassah Hospital; Liver Unit
Jerusalem, 91120, Israel
Clalit Strauss MC
Jerusalem, 95146, Israel
Meir Medical Center; Gastroenterology
Kfar Saba, 44281, Israel
Naharyia / Western Galilee MC; Gastro Unit
Nahariya, 22100, Israel
Holy Family Medical Center; Gastroenterology
Nazareth, Israel
Rabin Medical Center; Gastroenterology - Liver Unit
Petah Tikva, 49100, Israel
Hasharon Mc; Gastroenterology
Petah Tikva, Israel
Chaim Sheba Medical Center; Gastroenterology
Ramat Gan, 52621, Israel
Kaplan Medical Center; Gastroenterology Unit
Rehovot, 76100, Israel
Clalit Pinsker Rishon; Liver Clinic
Rishon LeZiyyon, 75299, Israel
Rebecca Sieff; Gastroenterology
Safed, 13110, Israel
Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit
Tel Aviv, 6423906, Israel
Clalit Zamenhoff
Tel Aviv, 64353, Israel
Maccabi Health Services MC
Tel Aviv, 67891, Israel
Poria Hospital; Gastroenterology
Tiberias, Israel
Assaf Harofeh; Gastroenterology
Ẕerifin, 6093000, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2011
First Posted
September 7, 2011
Study Start
September 25, 2008
Primary Completion
June 10, 2013
Study Completion
June 10, 2013
Last Updated
October 23, 2018
Results First Posted
October 23, 2018
Record last verified: 2017-12