Dose Escalation Study to Evaluate the Safety and Antivira... | NCT00227435

Studies
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C

NCT00227435

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Apr 27, 2016Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

Chronic Hepatitis C

Interventions

val-mCyd

Countries

United States

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Feb 2003

Primary Completion Date

Jul 2004Actual

Completion Date

Jul 2004Actual

First Submitted Date

Sep 26, 2005

First Submission Date that Met QC Criteria

Sep 26, 2005

First Posted Date

Sep 28, 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

Apr 25, 2016

Last Update Posted Date

Apr 27, 2016Estimated

Description Module

Brief Summary

This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
val-mCyd	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented clinical history of chronic hepatitis C and compensated liver disease
No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Patient is pregnant or breastfeeding
Patient is co-infected with HBV or HIV

Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Pasadena	California		United States