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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01334567
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Tenofovir DF Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108
Study Start Date : August 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tenofovir DF Drug: Tenofovir DF
Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators
Other Name: Viread®

Primary Outcome Measures :
  1. No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01334567

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Kaoshiung Hsien, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan Hsien, Taiwan
Sponsors and Collaborators
Gilead Sciences
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Study Director: John Flaherty, PharmD Gilead Sciences

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Responsible Party: Gilead Sciences Identifier: NCT01334567     History of Changes
Other Study ID Numbers: GS-US-174-0141
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents