Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a vs Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Chronic Hepatitis B(CHB). (TDF PEG CHB)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01277601
First received: January 13, 2011
Last updated: September 24, 2014
Last verified: September 2014

January 13, 2011
September 24, 2014
April 2011
August 2014   (final data collection date for primary outcome measure)
Proportion of participants with HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF alone [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF alone. [ Time Frame: 72 Weeks ] [ Designated as safety issue: No ]
The proportion of subjects with HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF alone.
Complete list of historical versions of study NCT01277601 on ClinicalTrials.gov Archive Site
  • Proportion of participants with HBsAg loss at Week 72 following treatment with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48 weeks or TDF alone [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Proportion of participants who experience HBsAg loss at Week 96 and Week 120 [ Time Frame: Weeks 96 and 120 ] [ Designated as safety issue: No ]
  • Proportion of participants with virological response (hepatitis B virus [HBV] DNA level < 117 IU/mL) at Weeks 72, 96, and 120 [ Time Frame: Weeks 72, 96, and 120 ] [ Designated as safety issue: No ]
  • Proportion of participants with serological response (HBeAg loss and seroconversion, and HBsAg seroconversion) at Weeks 72, 96, and 120 [ Time Frame: Weeks 72, 96, and 120 ] [ Designated as safety issue: No ]
  • Proportion of participants who experience biochemical response at Weeks 72, 96, and 120 [ Time Frame: Weeks 72, 96, and 120 ] [ Designated as safety issue: No ]
    Biochemical response is defined as having alanine aminotransferase (ALT) < 30 for males and < 19 for females (based on the American Association for the Study of Liver Diseases [AASLD] 2008 guidelines); ALT < 42 for males and < 32 for females (based on central lab upper limit of the normal range [ULN] for ALT).
  • Proportion of participants who require reinitiation or change of anti-HBV therapy while on therapy or posttreatment [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
  • HBsAg loss at Week 72 following treatment with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48 weeks or TDF alone [ Time Frame: 72 Weeks ] [ Designated as safety issue: No ]
    The proportion of subjects with HBsAg loss at Week 72 following treatment with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48 weeks or TDF alone.
  • HBsAg loss at Week 96 and Week 120 [ Time Frame: Week 96 and Week 120 ] [ Designated as safety issue: No ]
    The proportion of subjects who experience HBsAg loss at Week 96 and Week 120
  • Rate of quantitative HBsAg decline during the study [ Time Frame: Baseline through Week 120 ] [ Designated as safety issue: No ]
    The rate of quantitative HBsAg decline during the study
  • HBV DNA level < 400 copies/mL at Weeks 72, 96 and 120 [ Time Frame: Weeks 72, 96 and 120 ] [ Designated as safety issue: No ]
    The proportion of subjects with virological response (HBV DNA level < 400 copies/mL) at Weeks 72, 96 and 120
  • HBeAg loss and seroconversion, and HBsAg seroconversion at Weeks 72, 96 and 120 [ Time Frame: Weeks 72, 96 and 120 ] [ Designated as safety issue: No ]
    The proportion of subjects with serological response (HBeAg loss and seroconversion, and HBsAg seroconversion) at Weeks 72, 96 and 120
  • ALT<ULN at Weeks 72, 96 and 120 [ Time Frame: Weeks 72, 96 and 120 ] [ Designated as safety issue: No ]
    The proportion of subjects who experience biochemical response (ALT<ULN) at Weeks 72, 96 and 120
  • Requiring re-initiation or change of therapy while on therapy or post-treatment [ Time Frame: Baseline through Week 120 ] [ Designated as safety issue: Yes ]
    The proportion of subjects who require re-initiation or change of therapy while on therapy or post-treatment
Not Provided
Not Provided
 
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a vs Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Chronic Hepatitis B(CHB).
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

This study will evaluate the safety and efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (PEG) combination therapy versus standard of care TDF monotherapy or PEG monotherapy in non-cirrhotic adults with chronic hepatitis B virus.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: TDF
    Tenofovir disoproxil fumarate (TDF) 300 mg tablets administered orally once daily
    Other Name: Viread®
  • Drug: PEG
    Peginterferon α-2a (PEG) 180 µg administered via subcutaneous injection once weekly
    Other Name: Pegasys®
  • Experimental: TDF+PEG 48 wk
    Participants will receive TDF plus PEG concomitantly for 48 weeks.
    Interventions:
    • Drug: TDF
    • Drug: PEG
  • Experimental: TDF+PEG 16 wk, TDF 32 wk
    Participants will receive TDF plus PEG concomitantly for 16 weeks, followed by TDF alone for 32 weeks (total 48 weeks).
    Interventions:
    • Drug: TDF
    • Drug: PEG
  • Active Comparator: TDF 120 wk
    Participants will receive TDF continuously through 120 weeks.
    Intervention: Drug: TDF
  • Active Comparator: PEG 48 wk
    Participants will receive PEG for 48 weeks.
    Intervention: Drug: PEG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
751
July 2015
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults (aged 18-75) with CHB (positive for serum HBsAg or HBV DNA for at least 6 months) prior to baseline.
  • Anti-HBV treatment naive adults and adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
  • Positive or negative for HBeAg -HBV DNA ≥ 20,000 IU/ml for individuals with HBeAg+ and HBV DNA ≥ 2,000 IU/ml for individuals with HBeAg-
  • ALT >54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300 U/L for women
  • Creatinine clearance ≥ 70 mL/min
  • A negative serum pregnancy test is required for females of childbearing potential
  • All sexually active females of childbearing potential must agree to use a protocol recommended method of contraception during heterosexual intercourse throughout the study and for 30 days following the last dose of study medication.
  • Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product.

Exclusion Criteria:

  • Known bridging fibrosis or cirrhosis and/or decompensated liver disease
  • Evidence of hepatocellular carcinoma
  • Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
  • Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
  • History of severe depression or severe psychiatric disease
  • Thyroid dysfunction
  • Co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
  • Pregnant
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands,   Australia,   Hong Kong,   India,   Turkey,   Korea, Republic of,   Germany,   Greece,   Italy,   United Kingdom,   Taiwan,   France,   Portugal,   Singapore,   Romania,   Canada,   Spain,   Poland
 
NCT01277601
GS-US-174-0149
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Eduardo B Martins, MD, DP Gilead Sciences
Gilead Sciences
September 2014

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