Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

Chronic Hepatitis C Clinical Trial

Official title:

Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146016
• Other study ID #: CIRA-study
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: September 1, 2005
• Start date: February 2000
• Est. completion date: January 2007

Study information

• Verified date: September 2005
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C

Description:

The CIRA-study is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of (PEG-)interferon alpha 2b ((PEG)Intron-A®) and ribavirin (Rebetol®), with triple therapy, consisting of (PEG-)interferon alpha 2b, ribavirin and amantadine, for 52 weeks. Follow-up is completed at week 104. 150 Subjects per treatment group will be included. Patients will be stratified before randomisation according to genotype (1 versus non-1). Viral load will not be a discriminating factor.

The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Anti-HCV positivity >6 months

• ALT and/or AST elevation on at least once in the previous 6 months

• Positive HCV-RNA

• Liver biopsy within one year before the start of therapy in non- cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary

• Intention to be treated and participate treatment

• Obtained written informed consent

Exclusion Criteria:

• Age < 18 years

• Pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation

• Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy

• Life expectancy < 1 year

• Child Pugh B or C (Appendix III)

• Creatinine > 150 µmol/L or > 1.70 mg/dl

• Haemoglobulin < 6.5 mmol/l or < 10.5 g/dl

• White blood cell count < 2,5 x 109/L, neutrophil < 1,5 x 109/L

• Platelet count < 70 x 109/L

• HIV positivity

• Chemotherapy, systematical antiviral treatment during the 6 months prior to study entry

• Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)

• Active uncontrolled psychiatric disorders and suicidal leanings

• Patients with a history of uncontrolled seizure or other significant CNS dysfunction

• Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Amantadine

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Berg T, Kronenberger B, Hinrichsen H, Gerlach T, Buggisch P, Herrmann E, Spengler U, Goeser T, Nasser S, Wursthorn K, Pape GR, Hopf U, Zeuzem S. Triple therapy with amantadine in treatment-naive patients with chronic hepatitis C: a placebo-controlled trial. Hepatology. 2003 Jun;37(6):1359-67. — View Citation

Brillanti S, Levantesi F, Masi L, Foli M, Bolondi L. Triple antiviral therapy as a new option for patients with interferon nonresponsive chronic hepatitis C. Hepatology. 2000 Sep;32(3):630-4. — View Citation

Younossi ZM, McCullough AC, Barnes DS, Post A, Ong JP, O'Shea R, Martin LM, Bringman D, Farmer D, Levinthal G, Mullen KD, Carey WD, Tavill AS, Ferguson R, Gramlich T. Pegylated interferon alpha-2b, ribavirin and amantadine for chronic hepatitis C. Dig Dis Sci. 2005 May;50(5):970-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate at end of treatment and end of follow-up (sustained response rate)