DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

Intervention: GS-4774 (Drug); GS-9620 (Drug); Tenofovir disoproxil fumarate (TDF) (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Benedetta Massetto, MD, PhD, Study Director, Affiliation: Gilead Sciences

Summary

This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).

Clinical Details

Official title: A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48

Proportion of participants who remain HBsAg negative at Week 48

Secondary outcome:

Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144

Proportion of participants who achieve HBsAg loss at Weeks 48 and 144

Proportion of participants who remain HBsAg negative at Week 144

Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48

Proportions of participants with HBeAg loss and seroconversion at Week 144

Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48

Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144

Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144

Change from Baseline in HBV DNA at Weeks 48, 96, and 144

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more

than 120 days prior to Baseline (Day 1), except for participants from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol.

- Must have the ability to understand and sign a written informed consent form, which

must be obtained prior to initiation of study procedures

- Must be willing and able to comply with the visit schedule and study requirements

- Must have documented HBV DNA < 2,000 IU/mL at time of screening visit, which shall

occur no later than 1 year post last study visit in GS-US-174-0149

- Must have documented hepatitis B surface antigen (HBsAg) negative status anytime

during participation in GS-US-174-0149 regardless of ongoing HBV treatment Exclusion Criteria:

- Patient participating or planning to participate in another clinical study with an

investigational agent

- History of clinically-significant illness or any other major medical disorder that

may interfere with follow-up, assessments or compliance with the protocol

- Believed by the Study Investigator to be inappropriate for study participation for

any reason not otherwise listed

- Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm)

or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149

Locations and Contacts

Auckland City Hospital, Auckland, New Zealand

University of California, Los Angeles, Los Angeles, California, United States

Huntington Medical Research Institute, Pasadena, California, United States

Kaiser Permanente, Sacramento, California, United States

Kaiser Permanente, San Diego, California, United States

Kaiser Permanente, San Francisco, California, United States

Silicon Valley Research Institute, San Jose, California, United States

University of Miami, Miami, Florida, United States

Northwestern University, Chicago, Illinois, United States

Digestive Disease Associates, PA, Baltimore, Maryland, United States

Tufts Medical Center, Boston, Massachusetts, United States

University of Michigan, Ann Arbor, Michigan, United States

Henry Ford Hospital, Detroit, Michigan, United States

St. Louis University, St. Louis, Missouri, United States

Medical Procare, PLL, Flushing, New York, United States

North Shore - LIJ Health System, Manhasset, New York, United States

Bon Secours St. Mary's Hospital of Richmond, Newport News, Virginia, United States

Additional Information

Starting date: December 2014
Last updated: August 14, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017