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

Hepatitis B Clinical Trial

Official title:

A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334567
• Other study ID #: GS-US-174-0141
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2010
• Last updated: February 28, 2014
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis B

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs.		3 years	No