Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B
Intervention: Tenofovir DF (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s): John Flaherty, PharmD, Study Director, Affiliation: Gilead Sciences
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.
Clinical Details
Official title: A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs.
Eligibility
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kaoshiung Hsien, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan Hsien, Taiwan
Additional Information
Starting date: August 2010
Last updated: February 28, 2014
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