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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02258581
• Other study ID #: GS-US-330-1508
• Secondary ID: 2015-001050-16
• Status: Terminated
• Phase: N/A
• First received: October 3, 2014
• Last updated: September 29, 2017
• Start date: December 9, 2014
• Est. completion date: August 14, 2017

Study information

• Verified date: September 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 241
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

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

Intervention

Drug:
• GS-4774
Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection.
• GS-9620
Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
• Tenofovir disoproxil fumarate (TDF)
Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Canada	University of Calgary	Calgary	Alberta
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Gordon and Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	Liver and Intestinal Research Centre	Vancouver	British Columbia
Canada	University of Manitoba	Winnepeg	Manitoba
Hong Kong	Princess Margaret Hospital	Lai Chi Kok
Hong Kong	Prince of Wales Hospital	Sha Tin
India	Dept. of Hepatology, School of Digestive & Liver Diseases	Kolkata	West Bengal
India	Midas Multispecialty Hospital Private Limited	Nagpur	Maharashtra
India	Nirmal Hospital Private Limited	Surat	Gurarat
Italy	Azienda Ospedaliera Universitaria Pisana	Caianello	Pisa
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera Universitaria di Parma	Parma
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Korea, Republic of	Pusan National	Busan
Korea, Republic of	Korea University	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Yonsei University	Seoul
New Zealand	Auckland City Hospital	Auckland
United States	University of Michigan	Ann Arbor	Michigan
United States	Digestive Disease Associates, PA	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Henry Ford Hospital	Detroit	Michigan
United States	Medical Procare, PLL	Flushing	New York
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Northwell Health	Manhasset	New York
United States	University of Miami	Miami	Florida
United States	Bon Secours St. Mary's Hospital of Richmond	Newport News	Virginia
United States	Xiaoli Ma, PC	Philadelphia	Pennsylvania
United States	Kaiser Permanente	Sacramento	California
United States	St. Louis University	Saint Louis	Missouri
United States	Kaiser Permanente	San Diego	California
United States	Kaiser Permanente	San Francisco	California
United States	Silicon Valley Research Institute	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Hong Kong,  India,  Italy,  Korea, Republic of,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline = 0.5 log10 IU/ml from baseline at Week 48	This endpoint will be measured for participants who are HBsAg positive at baseline.	Week 48
Primary	Proportion of participants who remain HBsAg negative at Week 48	This endpoint will be measured for participants who are HBsAg negative at baseline.	Week 48
Secondary	Proportion of participants with serum HBsAg decline = 0.5 log10 IU/ml from baseline at Week 144	This endpoint will be measured for participants who are HBsAg positive at baseline.	Week 144
Secondary	Proportion of participants who achieve HBsAg loss at Weeks 48 and 144	This endpoint will be measured for participants who are HBsAg positive at baseline.	Weeks 48, 144
Secondary	Proportion of participants who remain HBsAg negative at Week 144	This endpoint will be measured for participants who are HBsAg negative at baseline.	Week 144
Secondary	Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48	This endpoint will be measured for participants who are HBeAg positive at baseline.	Week 48
Secondary	Proportions of participants with HBeAg loss and seroconversion at Week 144	This endpoint will be measured for participants who are HBeAg positive at baseline.	Week 144
Secondary	Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48	This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.	Week 48
Secondary	Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144	This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.	Week 144
Secondary	Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144	This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.	Weeks 48, 96 and 144
Secondary	Change from Baseline in HBV DNA at Weeks 48, 96, and 144		Baseline; Week 48; Week 96; Week 144