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

NCT00641654 | Terminated Phase 4

• 1 other identifier: EudractCT 2006-003409-18
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; genotype 2 or 3; relapse; pegylated interferon; ribavirin

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks after completion of the 24 or 48 week treatment period.

Secondary Outcomes (1)

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

  24 weeks after complection of the 24 or 48 week treatment

Study Arms (3)

A

ACTIVE COMPARATOR

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.

Drug: Pegylated interferon alfa-2a and ribavirin

B

ACTIVE COMPARATOR

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.

Drug: Pegylated interferon alfa-2a and ribavirin

C

ACTIVE COMPARATOR

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.

Drug: Pegylated interferon alfa-2a and ribavirin

Interventions

Pegylated interferon alfa-2a and ribavirin DRUG

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

Also known as: Pegasys, Copegus

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Göteborg University: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Dept of Infectious Diseases, Sahlgrenska University Hospital

Gothenburg, SE-416 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 23795661 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Recurrence

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Gunnar PE Norkrans, MD Prof

  Sahlgrenska University Hospital,Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: January 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 30, 2012

Record last verified: 2012-03

Locations

SE (1)