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To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732224
First Posted: November 22, 2012
Last Update Posted: March 23, 2016
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):
Institute of Liver and Biliary Sciences, India
  Purpose
The relevant data will be prospectively collected included patient demographics, clinical, all laboratory variables including virological tests, genotyping by direct sequencing, abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not evident whether the underlying liver disease was chronic based on clinical, biochemical, radiological investigations, and upper GI endoscopy. Severity of the liver disease will be assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD) score.

Condition Intervention
Spontaneous Reactivation of Hepatitis B Drug: Tenofovir + Telbivudine Drug: Tenofovir

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Study to Compare the Efficacy of Combined Tenofovir Plus Telbuvidine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B.

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Survival [ Time Frame: 1 and 3 months ]

Secondary Outcome Measures:
  • Reduction in HBV DNA. [ Time Frame: 7 days, 15 days, 1 month and 3 month ]
  • Drug(s) related adverse effects/ side effects [ Time Frame: 1 and 3 months ]
  • Improvement in CTP and MELD scores [ Time Frame: 1 and 3 months ]
  • Alteration of renal functions [ Time Frame: 1 and 3 months ]

Enrollment: 69
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenofovir + Telbivudine
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
Drug: Tenofovir
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
Active Comparator: Tenofovir
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
Drug: Tenofovir + Telbivudine
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Reactivation of CHB characterized by a rise in ALT level >5 times upper limit of normal along with HBV DNA level >10^5 copies/ mL (> 1.8 X 10^4 IU/mL).

Exclusion Criteria:

  1. Superinfection with other viruses (hepatitis E, A, D, or C)
  2. other causes of chronic liver failure
  3. coexistent hepatocellular carcinoma (HCC)
  4. portal vein thrombosis
  5. coexistent renal impairment
  6. pregnancy
  7. coinfection with human immunodeficiency virus (HIV)
  8. patients who had received a previous course of any antiviral, immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at least the preceding 12 months.
  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): NCT01732224


Locations
India
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Shiv Kumar Sarin, DM Institute of Liver & Biliary Sciences (ILBS).
  More Information

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01732224     History of Changes
Other Study ID Numbers: ILBS-HBV Reactivation-01
First Submitted: November 19, 2012
First Posted: November 22, 2012
Last Update Posted: March 23, 2016
Last Verified: November 2012

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Telbivudine
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


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