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Trial record 1 of 1 for:    NCT01320943
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Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB (FINITE CHB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320943
First Posted: March 23, 2011
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
March 9, 2011
March 23, 2011
July 27, 2017
August 29, 2017
August 29, 2017
April 26, 2011
July 28, 2016   (Final data collection date for primary outcome measure)
Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms [ Time Frame: Week 144 ]
HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Proportion of subjects with HBsAg loss at Week 144 in both study arms [ Time Frame: At Week 144 ]
HBsAg loss will be evaluated by proportion of subjects with HBsAg loss at Week 144 in both Arm A and Arm B using the Kaplan-Meier (KM) product limit method. Subjects who have not experienced HBsAg loss but discontinue from the study prior to Week 144 are considered censored at the last HBsAg collection date. Log-rank test statistic will be used to compare the time to HBsAg loss between the two treatment arms.
Complete list of historical versions of study NCT01320943 on ClinicalTrials.gov Archive Site
  • Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144 [ Time Frame: Weeks 96 and 144 ]
    HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.
  • Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms [ Time Frame: Baseline to Week 144 ]
    • The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF
    • When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF.
  • Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm [ Time Frame: Weeks 48, 96, and 144 ]
  • Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups) [ Time Frame: Baseline to Week 144 ]
    Viral suppression is defined as 2 consecutive assessments of HBV DNA < 400 copies/mL (69 IU/mL) through Week 144.
  • Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF) [ Time Frame: Baseline to Week 144 ]
  • Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms [ Time Frame: Week 96 ]
    HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
  • Seroconversion [ Time Frame: At Weeks 96 and 144 ]
    The proportion of subjects with seroconversion at Weeks 96 and 144 and will be summarized the same way as for the primary endpoint of proportion of subjects with HBsAg loss at Week 144
  • Restarting Therapy [ Time Frame: At Weeks 48, 96 and 144 ]
    The proportion of subjects who restart TDF therapy in Arm A (stop) at Weeks 48, 96 and 144 will be estimated using the Kaplan-Meier (KM) product limit method. Subjects who have not re-started TDF therapy but discontinue from the study will be considered as censored at the last laboratory collection date.
Not Provided
Not Provided
 
Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB
FINITE CHB - First Investigation in Stopping Tenofovir Disoproxil Fumarate (TDF) Treatment After Long Term Virologic Suppression in HBeAg-negative Chronic Hepatitis B

The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF arm) compared to participants who continue TDF (Continue TDF arm).

Only participants who already are on treatment with TDF monotherapy or TDF in combination with lamivudine or emtricitabine for at least 4 years and who achieved and maintained virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study. One treatment arm will stop the TDF therapy while the other treatment arm will continue the TDF therapy. Participants in the Stop TDF arm will be monitored very closely with special focus on biochemical flares (especially alanine aminotransferase (ALT) increases) and virological relapses (Hepatitis B viral load increases). If any participant in the Stop TDF arm exceeds one or more predefined limits for such flares or relapses, TDF treatment will be reinstituted.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: TDF
    Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily
    Other Name: Viread®
  • Other: Stop TDF
    Participants will stop TDF therapy
  • Experimental: Stop TDF
    Participants randomized to this arm will stop TDF therapy at baseline.
    Intervention: Other: Stop TDF
  • Active Comparator: Continue TDF
    Participants randomized to this arm will continue TDF therapy.
    Intervention: Drug: TDF
  • Berg T, Schott E, Felten G, Eisenbach C, Welzel TM, Warger T, et al. Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-Negative CHB: Two Cases From an Ongoing Randomized, Controlled Trial [Poster Number P47] The Viral Hepatitis Congress; 2012 September 7-9; Frankfurt am Main, Germany.
  • Berg T, Simon K-G, Mauss S, Schott E, Heyne R, Klass D, et al. Stopping Tenofovir Disoproxil Fumarate Treatment After Long-Term Virologic Suppression in HBeAg-Negative CHB: Week 48 Interim Results From an Ongoing Randomized, Controlled Trial ("FINITE CHB") [Presentation P119]. The European Association for the Study of the Liver (EASL). 50th International Liver Congress; 2015 22-26 April; Vienna, Austria.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
August 23, 2016
July 28, 2016   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Chronic hepatitis B, hepatitis B e-antigen negative, hepatitis B e-antibody positive, and hepatitis B surface antigen-positive
  • Hepatitis B e Antigen (HBeAg)-negative at the beginning of TDF therapy (i.e. TDF monotherapy or combination of TDF + lamivudine or TDF + emtricitabine)
  • Received continuous TDF therapy (i.e. TDF monotherapy or combination of TDF + lamivudine or TDF + emtricitabine) treatment for at least 4 years prior to screening. If TDF has been used in combination with lamivudine or emtricitabine, lamivudine or emtricitabine must have been stopped at least 12 weeks prior to screening
  • Documented hepatitis B virus DNA (HBV DNA) < 400 copies/mL for at least 3.5 years prior to screening and at screening
  • ALT within normal range
  • α-fetoprotein (AFP) <= 50 ng/mL
  • Calculated creatinine clearance >= 70 mL/min by Cockcroft-Gault formula using ideal body weight
  • <= 10 kPa on Fibroscan assessment
  • A negative serum pregnancy test for female subjects
  • Adult subjects >= 18 years of age

Key Exclusion Criteria:

  • Known cirrhosis
  • Evidence of fibrosis >= Stage 3 (METAVIR) on liver biopsy or Fibroscan > 10 kPa within 6 months prior to screening
  • Documentation of confirmed episodes (i.e., 2 consecutive values) of HBV DNA > 400 copies/mL within 3.5 years prior to screening
  • History of decompensated liver disease (defined as direct [conjugated] bilirubin > 1.5 x upper limit of normal, prothrombin time (PT) > 1.5 x upper limit of normal, platelets < 75,000/mm³, serum albumin < 3.0 g/dL
  • History of clinical hepatic decompensation in the judgement of the investigator
  • Evidence of hepatocellular carcinoma
  • Significant bone disease (in the judgment of the investigator)
  • Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
  • Known hypersensitivity to TDF, its metabolites, or formulation excipients
  • Concomitant therapy with disallowed medications
  • History of malignant disease
  • Lactating females
  • Females wishing to became pregnant during the duration of the stud
  • Subjects participating in another clinical trial can only be enrolled at the discretion of the Medical Monitor

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01320943
GS-EU-174-0160
2010-021925-12 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
July 2017

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