Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Subjects in United States

Chronic Hepatitis B Clinical Trial

Official title:

A Rollover Protocol to Provide Open-Label Emtricitabine/Tenofovir Disoproxil Fumarate Combination Product to Subjects Completing the GS-US-203-0107 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936715
• Other study ID #: GS-US-203-0109
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2009
• Last updated: December 11, 2015
• Start date: August 2009
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (DF) for an additional 5 years to subjects completing study GS-US-203-0107.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Complete all end of study visit procedures and PK substudy (if applicable) for the GS US 203 0107 study.

• A negative pregnancy test is required for female subjects at the end of study visit for GS US 203 0107 (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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs		5 years	No