A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR
1 other identifier
interventional
59
1 country
20
Brief Summary
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2009
Longer than P75 for phase_4
20 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
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
October 3, 2017
CompletedOctober 3, 2017
May 1, 2017
3.5 years
December 15, 2009
May 5, 2017
May 5, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
End of Treatment Response Rate at Week 72 in Genotype 1
End of treatment response rate at Week 72 was reported for genotype 1.
Week 72
End of Treatment Response in Genotype 2 and 3
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Week 48
Sustained Viral Response (SVR) Rates in CHC Genotype 1
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
Week 96
SVR Rates in Genotype 2 and 3.
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
Week 72
Secondary Outcomes (1)
Percentage of Participants With Adverse Event (AE)
Week 96
Study Arms (1)
Single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients \>/= 18 years of age
- Chronic hepatitis C, genotype 1, 2, 3
- Compensated liver disease
- Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
You may not qualify if:
- Decompensated liver disease
- Signs or symptoms of hepatocellular carcinoma
- Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Haemek Hospital; Gastroenterology
Afula, 18101, Israel
Clalit City Ashdod MC; Liver Clinic
Ashdod, 77444, Israel
Batyamon; Liver Unit
Bat Yam, 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
Kaplan Medical Center; Gastroenterology Unit
Rehovot, 76100, Israel
Clalit Pinsker Rishon; Liver Clinic
Rishon LeZiyyon, 75299, Israel
Rebecca Sieff Medical Center; Liver Unit
Safed, 13110, 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
- Hoffmann-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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
December 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 3, 2017
Results First Posted
October 3, 2017
Record last verified: 2017-05