Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan

NCT ID: NCT01334567

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to offer subjects from centers in Taiwan who successfully complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir DF for up to three additional years (144 weeks). Subjects will be followed per local standard of care. Serious adverse events (SAEs), drug accountability and patient disposition will be recorded.

Conditions

Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tenofovir DF

Group Type: EXPERIMENTAL

Tenofovir DF

Intervention Type: DRUG

Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators

Interventions

Tenofovir DF

Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators

Intervention Type: DRUG

Other Intervention Names

Viread®

Eligibility Criteria

Inclusion Criteria

• Complete all end of study visit procedures for the GS US 174-0108 study.
• Willing and able to provide written informed consent.
• A negative pregnancy test is required for female subjects at the end of study visit (i.e., screening visit for study GS-US-174-0141) for GS US 174-0108 (unless surgically sterile or greater than two years post-menopausal)
• All sexually active female subjects who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
• Male subjects who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.

Exclusion Criteria

• Not Applicable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Flaherty, PharmD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Kaoshiung Hsien, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taoyuan Hsien, , Taiwan

Countries

Taiwan

Other Identifiers

GS-US-174-0141

Identifier Type: -

Identifier Source: org_study_id