Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C | NCT00262483

Studies
Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C

NCT00262483

Sponsor

Vertex Pharmaceuticals Incorporated

Status

Completed

Last Update Posted

Dec 21, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Hepatitis C

Interventions

VX-950
ribavirin
peginterferon alfa-2a

Countries

United States
Puerto Rico

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

Dec 2007

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

Dec 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Dec 2, 2005

First Submission Date that Met QC Criteria

Dec 2, 2005

First Posted Date

Dec 6, 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

Dec 17, 2007

Last Update Posted Date

Dec 21, 2007Estimated

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of triple combination therapy.		retrospective and prospective

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin.		retrospective and prospective
Plasma HCV RNA levels		retrospective and prospective

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infected with hepatitis C virus

Exclusion Criteria:

Contraindications to peginterferon or ribavirin therapy.

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Vertex Pharmaceuticals Incorporated	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Call for information		San Antonio	Texas		United States
Call for information

Condition Browse Module

MeSH Terms

ID	Term
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
C486464	telaprevir
D012254	Ribavirin
C100416	peginterferon alfa-2a

Ancestor Terms

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
VX-950	Drug
ribavirin	Drug
peginterferon alfa-2a	Drug