Spontaneous Reactivation of Hepatitis BNCT01732224
To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
A study testing Tenofovir + Telbivudine and Tenofovir in people with Spontaneous Reactivation of Hepatitis B, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spontaneous Reactivation of Hepatitis B
- What is being tested?
- Tenofovir + Telbivudine and Tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Superinfection with other viruses (hepatitis E, A, D, or C)
- other causes of chronic liver failure
- coexistent hepatocellular carcinoma (HCC)
- portal vein thrombosis
- coexistent renal impairment
- pregnancy
- coinfection with human immunodeficiency virus (HIV)
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
About this study
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.
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.
- Conditions
- Spontaneous Reactivation of Hepatitis B
- Being tested
- Tenofovir + Telbivudine, Tenofovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir + TelbivudineDrug
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
TenofovirDrug
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir + Telbivudine | Experimental | Tenofovir (300 mg/day) plus telbivudine (600 mg/day). Receives: Drug: Tenofovir |
| Tenofovir | Active comparator | In tenofovir arm subjects will receive tenofovir (300 mg) once daily. Receives: Drug: Tenofovir + Telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 1 and 3 months
Secondary outcomes (4)
Reduction in HBV DNA.
Measured: 7 days, 15 days, 1 month and 3 month
Drug(s) related adverse effects/ side effects
Measured: 1 and 3 months
Improvement in CTP and MELD scores
Measured: 1 and 3 months
Alteration of renal functions
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Reactivation of Hepatitis BStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiv Kumar Sarin, DM, Principal investigator, Institute of Liver & Biliary Sciences (ILBS).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732224
- Sponsor's protocol ID
- ILBS-HBV Reactivation-01
- Status last verified
- Nov 2012
- First submitted
- 19 Nov 2012
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01732224
- Acronym / sponsor ID
- ILBS-HBV Reactivation-01
- Conditions
- Spontaneous Reactivation of Hepatitis B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir + Telbivudine | Experimental | Drug: TenofovirTenofovir (300 mg/day) plus telbivudine (600 mg/day). |
| Tenofovir | Active comparator | Drug: Tenofovir + TelbivudineIn tenofovir arm subjects will receive tenofovir (300 mg) once daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (8 listed)
- Superinfection with other viruses (hepatitis E, A, D, or C)
- other causes of chronic liver failure
- coexistent hepatocellular carcinoma (HCC)
- portal vein thrombosis
- coexistent renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir + TelbivudineTenofovir (300 mg/day) plus telbivudine (600 mg/day). | Drug | Tenofovir |
| TenofovirIn tenofovir arm subjects will receive tenofovir (300 mg) once daily. | Drug | Tenofovir + Telbivudine |
Primary outcome
Survival
Time frame: 1 and 3 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiv Kumar Sarin, DM principal investigator
Institute of Liver & Biliary Sciences (ILBS).
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir + Telbivudine and Tenofovir in people with Spontaneous Reactivation of Hepatitis B, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.