Back to resultsA 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)
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
ribavirin [Copegus]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Haemek Hospital; Gastroenterology
- Clalit City Ashdod MC; Liver Clinic
- Barzilai MC; Gastroenterology
- Batyamon; Liver Unit
- Soroka Medical Center; Liver Unit
- Soroka Medical Center; Gastroenterology
- Rambam Medical Center; Gastroenterology - Liver Unit
- Bnei-Zion Medical Center; Gastroenterology
- Carmel Hospital; Liver Unit
- Wolfson Hospital; Gastroenterology Unit
- Hadassah Hospital; Liver Unit
- Clalit Strauss MC
- Meir Medical Center; Gastroenterology
- Naharyia / Western Galilee MC; Gastro Unit
- Holy Family Medical Center; Gastroenterology
- Rabin Medical Center; Gastroenterology - Liver Unit
- Hasharon Mc; Gastroenterology
- Chaim Sheba Medical Center; Gastroenterology
- Kaplan Medical Center; Gastroenterology Unit
- Clalit Pinsker Rishon; Liver Clinic
- Rebecca Sieff; Gastroenterology
- Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit
- Clalit Zamenhoff
- Maccabi Health Services MC
- Poria Hospital; Gastroenterology
- Assaf Harofeh; Gastroenterology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
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.
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
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
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.
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.
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.
Secondary Outcome Measures
Percentage of Participants With pEVR to Study Treatment at Week 12
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.
Percentge of Participants With a cEVR to Study Treatmen at Week 12 of 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.
Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01429792
Brief Title
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 25, 2008 (Actual)
Primary Completion Date
June 10, 2013 (Actual)
Study Completion Date
June 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1013 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
standard treatment, subcutaneously weekly
Intervention Type
Drug
Intervention Name(s)
ribavirin [Copegus]
Intervention Description
standard treatment, orally daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
Description
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.
Time Frame
Week 12
Title
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
Description
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Time Frame
Week 12
Title
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
Description
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
Time Frame
Week 24
Title
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Description
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Time Frame
Week 4
Title
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
Description
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
Time Frame
Week 4
Title
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With pEVR to Study Treatment at Week 12
Description
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.
Time Frame
Week 12
Title
Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment
Description
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.
Time Frame
Week 12
Title
Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24
Description
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.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Haemek Hospital; Gastroenterology
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Clalit City Ashdod MC; Liver Clinic
City
Ashdod
ZIP/Postal Code
77444
Country
Israel
Facility Name
Barzilai MC; Gastroenterology
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Batyamon; Liver Unit
City
Bat Yam
Country
Israel
Facility Name
Soroka Medical Center; Liver Unit
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Soroka Medical Center; Gastroenterology
City
Beer Sheva
ZIP/Postal Code
84105
Country
Israel
Facility Name
Rambam Medical Center; Gastroenterology - Liver Unit
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Bnei-Zion Medical Center; Gastroenterology
City
Haifa
ZIP/Postal Code
33394
Country
Israel
Facility Name
Carmel Hospital; Liver Unit
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Wolfson Hospital; Gastroenterology Unit
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Hadassah Hospital; Liver Unit
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Clalit Strauss MC
City
Jerusalem
ZIP/Postal Code
95146
Country
Israel
Facility Name
Meir Medical Center; Gastroenterology
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Naharyia / Western Galilee MC; Gastro Unit
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Holy Family Medical Center; Gastroenterology
City
Nazareth
Country
Israel
Facility Name
Rabin Medical Center; Gastroenterology - Liver Unit
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Hasharon Mc; Gastroenterology
City
Petach Tikva
Country
Israel
Facility Name
Chaim Sheba Medical Center; Gastroenterology
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center; Gastroenterology Unit
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Clalit Pinsker Rishon; Liver Clinic
City
Rishon Lezion
ZIP/Postal Code
75299
Country
Israel
Facility Name
Rebecca Sieff; Gastroenterology
City
Safed
ZIP/Postal Code
13110
Country
Israel
Facility Name
Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Clalit Zamenhoff
City
Tel Aviv
ZIP/Postal Code
64353
Country
Israel
Facility Name
Maccabi Health Services MC
City
Tel Aviv
ZIP/Postal Code
67891
Country
Israel
Facility Name
Poria Hospital; Gastroenterology
City
Tiberias
Country
Israel
Facility Name
Assaf Harofeh; Gastroenterology
City
Zerifin
ZIP/Postal Code
6093000
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
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)
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