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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01732224
First received: November 19, 2012
Last updated: May 7, 2014
Last verified: November 2012

November 19, 2012
May 7, 2014
November 2012
April 2015   (final data collection date for primary outcome measure)
Survival [ Time Frame: 1 and 3 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • Drug(s) related adverse effects/ side effects [ Time Frame: 1 and 3 months ] [ Designated as safety issue: Yes ]
  • Improvement in CTP and MELD scores [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]
  • Alteration of renal functions [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
80
April 2015
April 2015   (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.
Both
18 Years to 65 Years
No
Contact: Dr Ankur Jindal, MD 9582670984 ankur.jindal3@gmail.com
India
 
NCT01732224
ILBS-HBV Reactivation-01
No
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