NCT00194480

CompletedPhase 4

Treatment of Acute Hepatitis C Virus Infection With Pegylate...

National Institute on Drug Abuse (NIDA)Source

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

NIDA-16066-1

Secondary identifiers

R21DA016066-01

NIH

Study Type

interventional

Actual enrollment (reported)

21

Locations

1 country

Sites

1

Timeline

Study Start

April 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2006

Actual (reported)

Study Completion

June 2007

Actual (reported)

Brief Summary

Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV) infections. The purpose of this trial is to investigate the effectiveness of pegylated interferon in treating injection drug users (IDUs) with acute HCV.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 21 participants
Study completion date: June 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 12, 2005
Actual (reported)
First Posted
September 19, 2005
Actual (reported)
Primary Completion
December 2006
Actual (reported)
Study Completion
June 2007
Actual (reported)

Last Updated: January 12, 2017
Status Verified: October 2008
Last Update Submitted: January 11, 2017

Conditions

Hepatitis Substance-Related Disorders

Keywords

Hepatitis C, peg-Interferon, drug abuse

Outcome Measures

Primary Outcomes (1)

Sustained viral response rate in treatment group versus control (measured at Week 24)
24 weeks

Secondary Outcomes (1)

Adherence rate in the treatment group (measured at Week 24)
24 weeks

Study Arms (1)

PegInterferon

EXPERIMENTAL

Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)

Drug: Pegylated Interferon

Interventions

Pegylated InterferonDrug

Weekly injections of pegIntereferon

PegInterferon

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age15 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Documented HCV antibody seroconversion within the 12 months prior to study entry
Serum positive for HCV

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHlead
University of Washington
Othercollaborator

Study Sites (1)

Harborview Medical Center, 325 Ninth Ave 1EC32

Seattle, Washington, 98104, United States

MeSH Terms

Conditions

Substance-Related DisordersHepatitisHepatitis C

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus Infections

Study Officials

Chia Wang, MD, MS
University of Washington
PRINCIPAL INVESTIGATOR

Enrollment

21 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: NIH

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

April 2003

Date type not reported

This date has not been verified as actual or estimated.

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Meets hematologic, biochemical, and serologic criteria at entry visit

Thyroid stimulating hormone within normal limits

Hepatitis B surface antigen negative

Reads at an eighth grade reading level

Willing to use adequate contraception for the duration of the study

Plans to remain in the study area for 12 months

You may not qualify if:

Positive test for Hepatitis A antibodies, Hepatitis B antibodies, or HIV antibodies
Suspected hypersensitivity to pegylated interferon
Liver disease
Hemoglobinopathies
Immune mediated disease
Significant cardiac or pulmonary disease
Uncontrolled seizure disorder
Renal insufficiency with serum creatinine levels greater than 11.5 mb/ml or less than 60 mb/ml
History of thyroid disease
Active gout
Any medical condition requiring or likely to require steroids during the course of study
Untreated severe psychiatric disorder, as determined by study psychiatrist
Any condition, which in the opinion of the investigator, would preclude successful completion of the study
Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Primary Completion

December 2006

Actual (reported)

Study Completion

June 2007

Actual (reported)

Last Updated

January 12, 2017

Record last verified: 2008-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00194480
Data provider: ClinicalTrials.gov
Source updated: 2017-01-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:01 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

PegInterferon

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations