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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Amantadine
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, Amantadine, Triple therapy

Eligibility Criteria

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

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

Sites / Locations

  • UMC Utrecht

Outcomes

Primary Outcome Measures

Response rate at end of treatment and end of follow-up (sustained response rate)

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
September 1, 2005
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT00146016
Brief Title
Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
Official Title
Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht

4. Oversight

5. Study Description

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

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, Amantadine, Triple therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
390 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amantadine
Primary Outcome Measure Information:
Title
Response rate at end of treatment and end of follow-up (sustained response rate)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel v. Erpecum, MD, PhD
Organizational Affiliation
UMC Utrecht, dept. Gastroenterology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melvin Samsom, MD, PhD
Organizational Affiliation
UMC Utrecht, dept gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
12774015
Citation
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. doi: 10.1053/jhep.2003.50219.
Results Reference
background
PubMed Identifier
10960460
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. doi: 10.1053/jhep.2000.16235.
Results Reference
background
PubMed Identifier
15906777
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. doi: 10.1007/s10620-005-2673-y.
Results Reference
background
PubMed Identifier
20729740
Citation
Van Vlerken LG, Van Soest H, Janssen MP, Boland GJ, Drenth JP, Burger DM, Siersema PD, Van Erpecum KJ. Suboptimal endogenous erythropoietin response in chronic hepatitis C patients during ribavirin and PEG interferon treatment. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1308-15. doi: 10.1097/MEG.0b013e32833e784d.
Results Reference
derived

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

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