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Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin (RelapC)

Primary Purpose

Chronic Hepatitis C

Status
Terminated
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Pegylated interferon alfa-2a and ribavirin
Pegylated interferon alfa-2a and ribavirin
Pegylated interferon alfa-2a and ribavirin
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, genotype 2 or 3, relapse, pegylated interferon, ribavirin

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female patients ≥ 18 years of age
  • Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
  • Serum HCV-RNA ≥ 15 IU/mL. HCV genotype 2 or/and 3 infection confirmed within the past 6 months preceding the initiation of test drug dosing. The HCV genotype must have been reconfirmed after the termination of the previous treatment period
  • Previous relapse (i.e. HCV-RNA < 50 IU/mL at end of previous therapy) after one treatment period with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
  • A minimum of 24 weeks must have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period before the patients can be included in this study
  • Compensated liver disease (Child-Pugh Grade A clinical classification)
  • Patients with suspected cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP < 100 ng/mL within 2 months of randomization
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
  • All fertile males and females receiving ribavirin must be using effective contraception during treatment and during the 6 months after treatment end
  • Having a liver biopsy obtained within 5 years of this study is encouraged, but optional in accordance with local treatment traditions.

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • Previous non-response during treatment (as defined as having detectable HCV RNA ≥ 50 IU/ml at the end of previous treatment) with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
  • Less than 24 weeks have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period prior to inclusion in this study.
  • Therapy with any systemic anti-viral

    • anti-neoplastic
    • immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤ 6 months prior to the first dose of study drug
  • Any investigational drug ≤ 6 weeks prior to the first dose of study drug. HCV genotype 1, 4, 5 or 6 infection
  • Positive test at screening for anti-HAV IgM Ab

    • HBsAg
    • anti-HBc IgM Ab
    • anti-HIV Ab
  • Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • History or other evidence of decompensated liver disease
  • Neutrophil count < 1500 cells/mm3 or platelet count < 75,000 cells/mm3 at screening
  • Serum creatinine level > 2 mg/dl (> 124 µmol/L) or creatinine clearance < 50 ml/minute at screening
  • Severe psychiatric disease, especially depression, as judged by the treating physician
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease

    • severe chronic pulmonary disease associated with functional limitation
    • severe cardiac disease
    • major organ transplantation or other evidence of severe illness
    • malignancy
    • any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)
  • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or

    • clinically relevant ophthalmological disorder due to diabetes mellitus or
    • hypertension
  • Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic traditions. (Patients receiving Methadone or Subutex therapy may be included in this study.)
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study
  • Male partners of women who are pregnant
  • Hemoglobin < 11.3 g/dL (< 7.0 mmol/L) in women or < 12.9 g/dL (< 8.0 mmol/L) in men at screening.
  • Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, etc) or for whom anemia would be medically problematic
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated

Sites / Locations

  • Dept of Infectious Diseases, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

Patients having previously received 24 weeks of therapy with pegylated interferon and ribavirin will be treated with pegylated interferon alfa-2a kD (PEGASYS) plus ribavirin, (Copegus) for a treatment period of 48 weeks, with a follow-up period of 24 weeks irrespective of the level of HCV-RNA measured in plasma on treatment day 27.

Patients having previously received less than 24 weeks but at least 12 weeks of therapy with pegylated interferon and Ribavirin and having detectable HCV-RNA in a plasma sample obtained on treatment day 27 (i.e. the day before the 5th dose of pegylated interferon in this study) as analyzed by means of COBAS TaqMan 48TM will be treated with pegylated interferon alfa-2a KD (PEGASYS®) plus ribavirin, (Copegus®) for a treatment period of 48 weeks, with a follow-up period of 24 weeks.

Patients having previously received less than 24 weeks but at least 12 weeks of therapy with pegylated interferon and Ribavirin and having undetectable HCV-RNA in a plasma sample obtained on treatment day 27 (i.e. the day before the 5th dose of pegylated interferon in this study) as analyzed by means of COBAS TaqMan 48TM will be treated with pegylated interferon alfa-2a KD (PEGASYS®) plus ribavirin, (Copegus®) for a treatment period of 24 weeks, with a follow-up period of 24 weeks.

Outcomes

Primary Outcome Measures

Sustained viral response (SVR) rate defined as percentage of patients with non-detectable HCV-RNA 24 weeks after completion of the 24 or 48 week treatment period.

Secondary Outcome Measures

Sustained viral response (SVR)rate and percentage of patients with normal serum ALT levels and its association with prespecified factors e.g. viral load

Full Information

First Posted
March 17, 2008
Last Updated
August 29, 2012
Sponsor
Göteborg University
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00641654
Brief Title
Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin
Acronym
RelapC
Official Title
An Open-label Multicenter Study Evaluating the Efficacy and Safety of 24 or 48 Weeks Pegylated Interferon Alfa-2a 40 kD (PEGASYS) Combination Therapy With Ribavirin (Copegus) in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After a Minimum of 12 Weeks and a Maximum of 24 Weeks of Therapy With Pegylated Interferon and Ribavirin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems in Denmark and Norway
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA <50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior treatment) previous therapy with pegylated interferon and ribavirin given for at least 12 weeks and at most 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic hepatitis C, genotype 2 or 3, relapse, pegylated interferon, ribavirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients having previously received 24 weeks of therapy with pegylated interferon and ribavirin will be treated with pegylated interferon alfa-2a kD (PEGASYS) plus ribavirin, (Copegus) for a treatment period of 48 weeks, with a follow-up period of 24 weeks irrespective of the level of HCV-RNA measured in plasma on treatment day 27.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients having previously received less than 24 weeks but at least 12 weeks of therapy with pegylated interferon and Ribavirin and having detectable HCV-RNA in a plasma sample obtained on treatment day 27 (i.e. the day before the 5th dose of pegylated interferon in this study) as analyzed by means of COBAS TaqMan 48TM will be treated with pegylated interferon alfa-2a KD (PEGASYS®) plus ribavirin, (Copegus®) for a treatment period of 48 weeks, with a follow-up period of 24 weeks.
Arm Title
C
Arm Type
Active Comparator
Arm Description
Patients having previously received less than 24 weeks but at least 12 weeks of therapy with pegylated interferon and Ribavirin and having undetectable HCV-RNA in a plasma sample obtained on treatment day 27 (i.e. the day before the 5th dose of pegylated interferon in this study) as analyzed by means of COBAS TaqMan 48TM will be treated with pegylated interferon alfa-2a KD (PEGASYS®) plus ribavirin, (Copegus®) for a treatment period of 24 weeks, with a follow-up period of 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alfa-2a and ribavirin
Other Intervention Name(s)
Pegasys, Copegus
Intervention Description
Arm A: Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alfa-2a and ribavirin
Other Intervention Name(s)
Pegasys, Copegus
Intervention Description
Arm B:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alfa-2a and ribavirin
Other Intervention Name(s)
Pegasys, Copegus
Intervention Description
Arm C:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 24 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 24 weeks
Primary Outcome Measure Information:
Title
Sustained viral response (SVR) rate defined as percentage of patients with non-detectable HCV-RNA 24 weeks after completion of the 24 or 48 week treatment period.
Time Frame
24 weeks after completion of the 24 or 48 week treatment period.
Secondary Outcome Measure Information:
Title
Sustained viral response (SVR)rate and percentage of patients with normal serum ALT levels and its association with prespecified factors e.g. viral load
Time Frame
24 weeks after complection of the 24 or 48 week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients ≥ 18 years of age Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test Serum HCV-RNA ≥ 15 IU/mL. HCV genotype 2 or/and 3 infection confirmed within the past 6 months preceding the initiation of test drug dosing. The HCV genotype must have been reconfirmed after the termination of the previous treatment period Previous relapse (i.e. HCV-RNA < 50 IU/mL at end of previous therapy) after one treatment period with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks A minimum of 24 weeks must have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period before the patients can be included in this study Compensated liver disease (Child-Pugh Grade A clinical classification) Patients with suspected cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP < 100 ng/mL within 2 months of randomization Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug All fertile males and females receiving ribavirin must be using effective contraception during treatment and during the 6 months after treatment end Having a liver biopsy obtained within 5 years of this study is encouraged, but optional in accordance with local treatment traditions. Exclusion Criteria: Women with ongoing pregnancy or breast feeding Previous non-response during treatment (as defined as having detectable HCV RNA ≥ 50 IU/ml at the end of previous treatment) with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks Less than 24 weeks have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period prior to inclusion in this study. Therapy with any systemic anti-viral anti-neoplastic immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤ 6 months prior to the first dose of study drug Any investigational drug ≤ 6 weeks prior to the first dose of study drug. HCV genotype 1, 4, 5 or 6 infection Positive test at screening for anti-HAV IgM Ab HBsAg anti-HBc IgM Ab anti-HIV Ab Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) History or other evidence of decompensated liver disease Neutrophil count < 1500 cells/mm3 or platelet count < 75,000 cells/mm3 at screening Serum creatinine level > 2 mg/dl (> 124 µmol/L) or creatinine clearance < 50 ml/minute at screening Severe psychiatric disease, especially depression, as judged by the treating physician History of a severe seizure disorder or current anticonvulsant use History of immunologically mediated disease severe chronic pulmonary disease associated with functional limitation severe cardiac disease major organ transplantation or other evidence of severe illness malignancy any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range) Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic traditions. (Patients receiving Methadone or Subutex therapy may be included in this study.) Inability or unwillingness to provide informed consent or abide by the requirements of the study Male partners of women who are pregnant Hemoglobin < 11.3 g/dL (< 7.0 mmol/L) in women or < 12.9 g/dL (< 8.0 mmol/L) in men at screening. Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, etc) or for whom anemia would be medically problematic Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar PE Norkrans, MD Prof
Organizational Affiliation
Sahlgrenska University Hospital,Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Infectious Diseases, Sahlgrenska University Hospital
City
Goteborg
ZIP/Postal Code
SE-416 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23795661
Citation
Lagging M, Rembeck K, Rauning Buhl M, Christensen P, Dalgard O, Farkkila M, Hellstrand K, Langeland N, Lindh M, Westin J, Norkrans G. Retreatment with peg-interferon and ribavirin in patients with chronic hepatitis C virus genotype 2 or 3 infection with prior relapse. Scand J Gastroenterol. 2013 Jul;48(7):839-47. doi: 10.3109/00365521.2013.793389.
Results Reference
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Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin

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