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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

Information source: Gteborg University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Pegylated interferon alfa-2a and ribavirin (Drug); Pegylated interferon alfa-2a and ribavirin (Drug); Pegylated interferon alfa-2a and ribavirin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Gteborg University

Official(s) and/or principal investigator(s):
Gunnar PE Norkrans, MD Prof, Principal Investigator, Affiliation: Sahlgrenska University Hospital,Göteborg University

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dept of Infectious Diseases, Sahlgrenska University Hospital, Goteborg SE-416 85, Sweden
Additional Information

Starting date: January 2007
Last updated: August 29, 2012

Page last updated: August 23, 2015

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