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Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients

NCT ID: NCT00724776

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Brief Summary

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This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients

Detailed Description

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Conditions

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Chronic Hepatitis C

Keywords

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Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Open-label treatment with albinterferon alfa 2b escalating single dose

Group Type EXPERIMENTAL

Albinterferon alfa 2b

Intervention Type BIOLOGICAL

recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0

Interventions

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Albinterferon alfa 2b

recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Have a clinical diagnosis of CHC established on the basis of a detectable viral load as measured by a serum HCV RNA test at least 6 months before and during the screening period.
* Age 20 to 69 years
* Have compensated liver disease results on screening laboratory assessment

Exclusion Criteria

* Evidence of decompensated liver disease and/or liver cirrhosis.
* Body weight \< 50 kg.
* A history of immunologically mediated disease.
* A history or other clinical evidence of interstitial lung disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Pharmaceuticals, Japan

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3261

Results for CABF656A1202 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CABF656A1202

Identifier Type: -

Identifier Source: org_study_id