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

Purpose

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

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: Amantadine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Amantadine hydrochloride Amantadine Interferon Ribavirin Interferon Alfa-2a Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

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

Estimated Enrollment:	390
Study Start Date:	February 2000
Estimated Study Completion Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146016

Locations

Netherlands
UMC Utrecht
Utrecht, Netherlands, 3508 GA

Sponsors and Collaborators

UMC Utrecht

Investigators

Principal Investigator:	Karel v. Erpecum, MD, PhD	UMC Utrecht, dept. Gastroenterology
Principal Investigator:	Melvin Samsom, MD, PhD	UMC Utrecht, dept gastroenterology

More Information

Publications:

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.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00146016 History of Changes
Other Study ID Numbers:	CIRA-study
Study First Received:	September 1, 2005
Last Updated:	September 1, 2005
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:

Chronic Hepatitis C
Amantadine
Triple therapy

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a

Amantadine
Interferons
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antiparkinson Agents

ClinicalTrials.gov processed this record on May 16, 2013