Peginterferon Alfa-2a, Ribavirin, Amantadine/Placebo in Hepatitis C Virus (HCV)-Genotype-1-Infection (PRAMA)

NCT00127777 | Unknown Phase 4

• 1 other identifier: ML17002
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare the efficacy and tolerability of a 48-week combined therapy with pegylated interferon alpha-2a, ribavirin and amantadine sulphate versus placebo in untreated patients with chronic hepatitis C virus-genotype-1-infection. The hypothesis was that there will be an increase in sustained response rate for triple therapy compared to current standard treatment.

Conditions

Hepatitis C, Chronic

Keywords

HCV genotype 1; peginterferon alfa-2a; ribavirin; amantadine; treatment-naive

Outcome Measures

Primary Outcomes (1)

• Proof that peginterferon alfa-2a, ribavirin and amantadine sulphate over a period of 50 weeks improves the permanent virological efficacy by more than 10% compared to peginterferon alfa-2a and ribavirin

Secondary Outcomes (4)

• Verification of the initial virological efficacy up to week 12, defined as negative HCV-RNA test results by means of quantitative proof methods, e.g. Roche AmplicorTM HCV Monitor v.2.0 (sensitivity <600 IE/ml)

• Biochemical efficacy, defined by the serum GPT values 24 weeks after the end of the therapy

• Virological efficacy, measured on the basis of the HCV-RNA values at the end of the therapy

• Biochemical efficacy defined by the serum GPT values at the end of the therapy

Interventions

Amantadine sulphate (in addition to standard treatment) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male subjects over 18 years of age and below 70 years of age
• Serological indication of chronic hepatitis C infection with positive anti-HCV test and serum HCV-RNA quantification \>600 IE/ml by means of quantitative proof methods, e.g. Roche AmplicorTM HCV Monitor test, v.2.0.
• Untreated patients with HCV-induced chronic infection.
• Indication of a genotype HCV-1 on the basis of the reverse hybridizing assay Inno LiPA from Bayer Versant (Innogenetics).
• Increased GPT serum level on at least one determination date within the 56-day screening phase prior to start of administration of study medication.
• Histological identification of inflammatory activity in the liver, with or without an indication of compensated cirrhosis, during the 24 months prior to start of the study.
• Compensated liver disease (Child-Pugh Grade A).
• Negative urine or serum pregnancy test in fertile female subjects within 24 hours before taking the first dose of study medication.
• During the administration of study medication and for 24 weeks after the treatment has stopped, patients must apply two approved contraception methods, one of which must have a barrier effect on the male, e.g. condom.

You may not qualify if:

• Any known sensitive reaction to interferon, ribavirin or amantadine sulphate.
• Pregnant or breast-feeding women and fertile women who do not practice contraception.
• Male partners of pregnant women.
• Previous treatment with interferon and/or ribavirin.
• Treatment with systemic anti-neoplastic or immunomodulatory medication (supraphysiologic doses of steroids or radiation included) within the last 6 months prior to the study and throughout the whole study.
• Immunosuppressed/immunocompromised patients.
• Participation in a clinical study within the last three months.
• Infection with HCV genotype-2, -3, -4, -5 or -6.
• Positive indication of HBsAg, HIV antibodies in the screening phase.
• Non-hepatitis C virus-induced chronic hepatitis (e.g. hematochromatosis, autoimmune hepatitis, metabolic or alcoholic liver disease).
• Decompensated liver cirrhosis or liver disease; Child-Pugh Grade B or C; or threshold compensated liver disease.
• Signs of a hepatocellular carcinoma within 2 months before the randomization, coupled with existing or developing cirrhosis.
• History of oesophagus varices haemorrhage.
• Hemoglobin \<12 g/dl in female subjects and \<13 g/dl in male subjects in the screening phase.
• Subjects with a higher risk of anemia (e.g. thalassemia, spherocytosis, history of gastrointestinal bleeding) or subjects for whom anemia could be a highly potential medical risk.

Sponsors & Collaborators

• University Hospital, Saarland: lead
• Hoffmann-La Roche: collaborator

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Amantadine

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)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Stefan Zeuzem, MD

  Saarland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2005
• First Posted: August 8, 2005
• Study Start: July 1, 2002
• Study Completion: December 1, 2006
• Last Updated: August 25, 2005

Record last verified: 2005-08