A Study to Evaluate the Safety and Efficacy of Celgosivir... | NCT00157534

Studies
A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection

NCT00157534

Sponsor

BioWest Therapeutics Inc

Status

Completed

Last Update Posted

Sep 12, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Hepatitis C, Chronic

Interventions

Celgosivir

Countries

Not provided

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

Sep 2005

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

Oct 2004

Primary Completion Date

Not provided

Completion Date

Aug 2005

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 12, 2005Estimated

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

Sep 7, 2005

Last Update Posted Date

Sep 12, 2005Estimated

Description Module

Brief Summary

The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Celgosivir	Drug

Measure	Description	Time Frame
Safety analysis

Measure	Description	Time Frame
Hepatitis C viral load

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient must be 18 to 65 years of age, inclusive.
Primary diagnosis of chronic HCV infection.

Exclusion Criteria:

Patients who did not respond or relapsed following therapy with interferon.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jim Pankovich	BioWest Therapeutics Inc	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C070715	celgosivir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided