NCT00917358

Brief Summary

Interferon-based monotherapy has been considered effective to treat acute hepatitis C in ordinary patients. However, the efficacy of this treatment has not been evaluated in prospective interventional studies for dialysis patients. The aim of the study is the evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute hepatitis C who did not receive intervention as the reference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2005

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

2.9 years

First QC Date

June 8, 2009

Last Update Submit

December 19, 2012

Conditions

Hepatitis C

Keywords

Hepatitis CDialysisInterferon

Outcome Measures

Primary Outcomes (1)

  • Sustained virologic response (SVR)

    1.0 year

Study Arms (2)

Pegylated interferon alfa-2a

EXPERIMENTAL

Pegylated interferon alfa-2a 135 ug/week for 24 weeks

Drug: Pegylated interferon alfa-2a

Observation

NO INTERVENTION

Retrospectively chart review of dialysis patients with acute hepatitis C who did not receive any intervention

Interventions

Pegylated interferon alfa-2aDRUG

Pegylated interferon alfa-2a 135 ug/week for 24 weeks

Also known as: Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)
Pegylated interferon alfa-2a

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years old
  • Creatinine clearance (Ccr) \< 10 ml/min/1.73 m2
  • Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive \< 6 months with defined seroconversion
  • Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml

You may not qualify if:

  • Severe anemia (hemoglobin \< 10 g/dL) or hemoglobinopathy
  • Neutropenia (neutrophil count, \<1,500/mm3)
  • Thrombocytopenia (platelet \<90,000/ mm3)
  • Co-infection with HBV or HIV
  • Chronic alcohol abuse (daily consumption \> 20 g/day)
  • Autoimmune liver disease
  • Decompensated liver disease (Child classification B or C)
  • Neoplastic disease
  • An organ transplant
  • Immunosuppressive therapy
  • Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
  • Evidence of drug abuse
  • Unwilling to have contraception
  • Unwilling to sign inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Buddhist Tzu Chi General Hospital

Chiayi City, Taiwan

Location

Chiayi Christian Hospital

Chiayi City, Taiwan

Location

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Chen-Hua Liu, MD

    National Taiwan University Hospital

    STUDY CHAIR

  • Jia-Horng Kao, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Cheng-Chao Liang, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Shih-Jer Hsu, MD

    National Taiwan University Hospital, Yun-Lin Branch

    PRINCIPAL INVESTIGATOR

  • Hung-Bin Tsai, MD

    Buddhist Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

  • Peir-Haur Hung, MD

    Chiayi Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

July 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

TW(5)