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

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ClinicalTrials.gov Identifier: NCT00507689
Recruitment Status : Completed
First Posted : July 26, 2007
Results First Posted : September 19, 2013
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE July 25, 2007
First Posted Date  ICMJE July 26, 2007
Results First Submitted Date  ICMJE July 15, 2013
Results First Posted Date  ICMJE September 19, 2013
Last Update Posted Date March 14, 2014
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
Percentage of Participants With HBV Recurrence Prior to or at Week 72 [ Time Frame: Pretreatment baseline through Week 72 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2007)
Recurrence of Chronic Hepatitis B virus post liver transplant [ Time Frame: 1.5 to 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • Percentage of Participants With HBV Recurrence at Week 96 [ Time Frame: Week 96 ]
    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 ]
  • Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96 [ Time Frame: Week 96 ]
  • Percentage of Participants With Normal ALT at Week 72 [ Time Frame: Week 72 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
Official Title  ICMJE 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)
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
40
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2007)
50
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00507689
Other Study ID Numbers  ICMJE GS-US-203-0107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lewis Teperman, MD NYU Langone Health
PRS Account Gilead Sciences
Verification Date February 2014

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