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A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
COPEGUS
peginterferon alfa-2a [Pegasys]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Decompensated liver disease
  • Signs or symptoms of hepatocellular carcinoma
  • Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus

Sites / Locations

  • Haemek Hospital; Gastroenterology
  • Clalit City Ashdod MC; Liver Clinic
  • Batyamon; 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
  • Kaplan Medical Center; Gastroenterology Unit
  • Clalit Pinsker Rishon; Liver Clinic
  • Rebecca Sieff Medical Center; Liver Unit
  • 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

End of Treatment Response Rate at Week 72 in Genotype 1
End of treatment response rate at Week 72 was reported for genotype 1.
End of Treatment Response in Genotype 2 and 3
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
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.
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.

Secondary Outcome Measures

Percentage of Participants With Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Full Information

First Posted
December 15, 2009
Last Updated
May 5, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01033448
Brief Title
A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 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 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.

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
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
COPEGUS
Intervention Description
COPEGUS 800 mg or 1000-1200 mg po for 24 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
PEGASYS 180 micrograms sc once weekly for 24 weeks
Primary Outcome Measure Information:
Title
End of Treatment Response Rate at Week 72 in Genotype 1
Description
End of treatment response rate at Week 72 was reported for genotype 1.
Time Frame
Week 72
Title
End of Treatment Response in Genotype 2 and 3
Description
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Time Frame
Week 48
Title
Sustained Viral Response (SVR) Rates in CHC Genotype 1
Description
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
Time Frame
Week 96
Title
SVR Rates in Genotype 2 and 3.
Description
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants With Adverse Event (AE)
Description
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
Week 96

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 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 Exclusion Criteria: Decompensated liver disease Signs or symptoms of hepatocellular carcinoma Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
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
Batyamon; Liver Unit
City
Bat Yam
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
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 Medical Center; Liver Unit
City
Safed
ZIP/Postal Code
13110
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 of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

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