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

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ClinicalTrials.gov Identifier: NCT01732224
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Spontaneous Reactivation of Hepatitis B Drug: Tenofovir + Telbivudine Drug: Tenofovir Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
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.
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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Arms and Interventions
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Arm Intervention/treatment
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).


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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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 Posted: November 22, 2012    Key Record Dates
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