NCT00724776

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

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

July 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

December 8, 2020

Status Verified

August 1, 2010

Enrollment Period

1 year

First QC Date

July 28, 2008

Last Update Submit

December 6, 2020

Conditions

Chronic Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability after single dose

    5 weeks after single dose

Secondary Outcomes (1)

  • Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation

    5 weeks after single dose

Study Arms (1)

1

EXPERIMENTAL

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

Biological: Albinterferon alfa 2b

Interventions

Albinterferon alfa 2bBIOLOGICAL

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

1

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals, Japan

Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Hepatitis C, Chronic

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Last Updated

December 8, 2020

Record last verified: 2010-08

Locations

JP(1)