Albinterferon Alfa 2b Single Dose in Japanese Chronic Hep... | NCT00724776

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

NCT00724776

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 8, 2020Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Chronic Hepatitis C

Interventions

Albinterferon alfa 2b

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Not provided

First Submitted Date

Jul 28, 2008

First Submission Date that Met QC Criteria

Jul 28, 2008

First Posted Date

Jul 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2020

Last Update Posted Date

Dec 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Open-label treatment with albinterferon alfa 2b escalating single dose	Biological: Albinterferon alfa 2b

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Albinterferon alfa 2b	Biological	recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability after single dose		5 weeks after single dose

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation		5 weeks after single dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

Not provided

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections