NCT00146016

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

September 5, 2005

Status Verified

September 1, 2005

First QC Date

September 1, 2005

Last Update Submit

September 1, 2005

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis CAmantadineTriple therapy

Outcome Measures

Primary Outcomes (1)

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

Interventions

AmantadineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 12774015BACKGROUND

  • 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.

    PMID: 10960460BACKGROUND

  • 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.

    PMID: 15906777BACKGROUND

  • 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.

    PMID: 20729740DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Karel v. Erpecum, MD, PhD

    UMC Utrecht, dept. Gastroenterology

    PRINCIPAL INVESTIGATOR

  • Melvin Samsom, MD, PhD

    UMC Utrecht, dept gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

February 1, 2000

Study Completion

January 1, 2007

Last Updated

September 5, 2005

Record last verified: 2005-09

Locations

NL(1)