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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
November 19, 2012
November 22, 2012
March 23, 2016
November 2012
April 2014   (Final data collection date for primary outcome measure)
Survival [ Time Frame: 1 and 3 months ]
Same as current
Complete list of historical versions of study NCT01732224 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
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.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spontaneous Reactivation of Hepatitis B
  • Drug: Tenofovir + Telbivudine
    Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
  • Drug: Tenofovir
    In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
  • Experimental: Tenofovir + Telbivudine
    Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
    Intervention: Drug: Tenofovir
  • Active Comparator: Tenofovir
    In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
    Intervention: Drug: Tenofovir + Telbivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
April 2014
April 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01732224
ILBS-HBV Reactivation-01
No
Not Provided
Not Provided
Institute of Liver and Biliary Sciences, India
Institute of Liver and Biliary Sciences, India
Not Provided
Principal Investigator: Shiv Kumar Sarin, DM Institute of Liver & Biliary Sciences (ILBS).
Institute of Liver and Biliary Sciences, India
November 2012

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