Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00507689
First received: July 25, 2007
Last updated: February 12, 2014
Last verified: February 2014

July 25, 2007
February 12, 2014
September 2007
May 2011   (final data collection date for primary outcome measure)
Percentage of Participants With HBV Recurrence Prior to or at Week 72 [ Time Frame: Pretreatment baseline through Week 72 ] [ Designated as safety issue: No ]
HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.
Recurrence of Chronic Hepatitis B virus post liver transplant [ Time Frame: 1.5 to 2 years ]
Complete list of historical versions of study NCT00507689 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With HBV Recurrence at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.
  • Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Normal ALT at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.
  • Percentage of Participants With Normal ALT at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.
Not Provided
Not Provided
Not Provided
 
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
A Phase 2, Open-Label Randomized Study to Evaluate the Efficacy and Safety of the Combination Product, Emtricitabine/Tenofovir Disoproxil Fumarate in the Presence or Absence of Hepatitis B Immunoglobulin (HBIg) in Preventing Recurrence of Chronic Hepatitis B (CHB) Post-Orthotopic Liver Transplant (OLT)

The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis B following liver transplantation, in participants who were chronically infected with hepatitis B prior to transplantation.

Prior to enrollment, participants were required to have received at least 12 weeks of HBIg therapy following liver transplantation. Enrolled participants then received FTC/TDF plus HBIg for an initial 24-week pre-randomization treatment period. Participants who completed the pre-randomization period and who achieved sustained viral suppression were randomized to continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse events and various laboratory parameters.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Chronic Hepatitis B
  • Drug: FTC/TDF
    Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg was administered as a fixed-dose combination tablet orally once daily.
    Other Name: Truvada
  • Drug: Hepatitis B Immunoglobulin (HBIg)
    HBIg was administered either intravenously or by intramuscular injection at a dose and frequency as prescribed by the investigative site protocol.
  • Experimental: FTC/TDF+HBIg
    Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period.
    Interventions:
    • Drug: FTC/TDF
    • Drug: Hepatitis B Immunoglobulin (HBIg)
  • Experimental: FTC/TDF
    Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period.
    Intervention: Drug: FTC/TDF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult subjects (18-75 years of age) with either hepatitis e antigen (HBeAg) positive or HBeAg negative chronic HBV prior to transplant
  • Willing and able to provide written informed consent
  • Subjects with detectable antibody to hepatitis B surface antigen performed by a local laboratory result within 30 days of screening
  • Subjects must have been stable and may not have had 2 or more of the following laboratory parameters associated with decompensated liver disease: conjugated bilirubin > 1.5 x the upper limit of the normal range (ULN), prothrombin time > 1.5 x ULN, platelets < 60,000/mm^3, serum albumin < 3.0 g/dL
  • Must have had at least 12 weeks of center-specific prophylactic therapy including hepatitis B immunoglobulin (HBIg) posttransplant
  • Calculated creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault equation
  • No significant evidence of ongoing deterioration of renal function
  • Negative serum beta-human chorionic gonadotropin (for females of childbearing potential only)

Exclusion Criteria:

  • Subjects with HBV recurrence, ie, confirmed HBV DNA ≥ 400 copies/mL, following liver transplant
  • Pregnant women, women who were breast feeding or who believed they may have wished to become pregnant during the course of the study
  • Males and females of reproductive potential who were unwilling to use an effective method of contraception during the study and for at least 30 days from the date of last dose of study drug
  • Evidence of hepatocellular carcinoma (HCC), eg, alpha-fetoprotein > 50 ng/mL, or by any other standard of care measure or presence of multifocal HCC at the time of transplantation if transplantation was within 144 weeks of screening
  • Prior TDF or FTC/TDF experience post-transplant or > 12 months treatment with TDF or FTC/TDF treatment pretransplant
  • Coinfection with hepatitis C virus (by serology), HIV, or hepatitis D virus pretransplant or at screening
  • Significant renal, cardiovascular, pulmonary, or neurological disease
  • Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
  • Were likely to receive systemic drugs with nephrotoxic potential, except immunosuppressive agents (eg, cyclosporine, tacrolimus), during the course of the study
  • History of variceal bleeding or hepatic encephalopathy following orthotopic liver transplantation
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507689
GS-US-203-0107
No
Gilead Sciences
Gilead Sciences
Not Provided
Principal Investigator: Lewis Teperman, MD New York University School of Medicine
Gilead Sciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP