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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
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B Drug: TDF Other: Stop TDF Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FINITE CHB - First Investigation in Stopping Tenofovir Disoproxil Fumarate (TDF) Treatment After Long Term Virologic Suppression in HBeAg-negative Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 43
Actual Study Start Date: April 26, 2011
Study Completion Date: August 23, 2016
Primary Completion Date: July 28, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stop TDF
Participants randomized to this arm will stop TDF therapy at baseline.
Other: Stop TDF
Participants will stop TDF therapy
Active Comparator: Continue TDF
Participants randomized to this arm will continue TDF therapy.
Drug: TDF
Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily
Other Name: Viread®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320943


Locations
Germany
Leberzentrum am Checkpoint
Berlin, Germany, 10969
Charite CVK
Berlin, Germany, 13353
Zentrum für HIV und Hepatitis
Duesseldorf, Germany, 40237
J.W. Goethe Universitaetsklinikum
Frankfurt, Germany, 60590
ifi Studien und Projekte GmbH
Hamburg, Germany, 20099
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitaetsklinik Heidelberg
Heidelberg, Germany, 69120
Gastroenterologische Gemeinschaftspraxis
Herne, Germany, 44623
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Gemeinschaftspraxis Gastroenterologie
Leverkusen, Germany, 51375
Klinikum der LMU Grosshadern
Muenchen, Germany, 81377
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Publications:
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.

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01320943     History of Changes
Other Study ID Numbers: GS-EU-174-0160
2010-021925-12 ( EudraCT Number )
First Submitted: March 9, 2011
First Posted: March 23, 2011
Results First Submitted: July 27, 2017
Results First Posted: August 29, 2017
Last Update Posted: August 29, 2017
Last Verified: July 2017

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

Keywords provided by Gilead Sciences:
stopping oral antiviral therapy
HBsAg loss
seroconversion
restarting oral antiviral therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Tenofovir
Tin Fluorides
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs