Cirrhosis Due to Hepatitis BPhase 4NCT02238860
A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
A Phase 4 study testing Entacavir and Tenofovir in people with Cirrhosis Due to Hepatitis B, run by Asian Institute Of Medical Sciences at 1 site in Pakistan.
Trial summary
Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis Due to Hepatitis B
- What is being tested?
- Entacavir and Tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2014to Sep 2016
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (18 years- 70 years)
- Hbv surface antigen positive > 6 months
- HbeAg (positive or negative both)
- Hbv DNA 10^3
- ALT ULN
- No evidence of HCC
Show all 10Show fewer
- Platelets count > 30 thousands
- CTP score > 7
- Hepatic encephalopathy (grade 1 - 2 only)
- No prior Drug resistance
Who cannot join
- Age < 18 years
- HCC patients
- Prior drug resistance
- Current HE > 2
- Solid organ transplantation
- Inadequate hematological function
Show all 11Show fewer
- Co infection with hepatitis C and HIV
- Autoimmune disorders
- Pregnancy and Breast feeding
- Other hepatic diseases
- Patients on immunosuppressant or chemotherapy agents
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Asian Institute of medical Sciences
Hyderābād, Sindh, 71800
Dr mohammad sadik Memon, FCPS gastro, 022-232593, Sadikmemon@gmail.com
Dr sadik Memon, FCPS gastro
About this study
Official title: A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.
Read the detailed description
The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.
- Conditions
- Cirrhosis Due to Hepatitis B
- Being tested
- Entacavir, Tenofovir
- Keywords
- Hepatitis B, cirrhosis, Entacavir, enofovir
- Medical subject headings
- Hepatitis B, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntacavirDrug
Also called ETV
Entacavir-0.5 mg ,OD,for
TenofovirDrug
Also called TDF or PMPA
Tenofovir ,300 mg,OD,for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Entacavir | Active comparator | Entacavir 0.5 mg (OD) for 48 weeks Receives: Drug: Entacavir; Drug: Tenofovir |
| Tenofovir | Active comparator | Tenofovir 300 mg ,OD for 48 weeks Receives: Drug: Entacavir; Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy
EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.
Measured: 48 weeks
Secondary outcomes (1)
Safety
SAFETY ENDPOINTS: SAFETY ANALYSIS INCLUDED CUMALATIVE RATES ON TREATMENT ADVERSE EVENTS, SEREIOUS ADVERSE EFFECTS DISCONTINUATION DUE TO SIDE EFFECTS,DEATH,HCC,RENAL IMPAIRMENT , HEPATIC FLARE AND DEVELOPMENT OF DRUG RESISTANCE.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis Due to Hepatitis BStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad sadik memon, Asian Institute Of Medical Sciences
- Investigators
- Mohammad sadik Memon, Fcps gastro, Principal investigator, AIMS Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238860
- Sponsor's protocol ID
- AIMS-hep B-123
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT02238860
- Acronym / sponsor ID
- AIMS-hep B-123
- Conditions
- Cirrhosis Due to Hepatitis B
- Keywords
- Hepatitis B, cirrhosis, Entacavir, enofovir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asian Institute Of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 12 Sep 2014 (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.
Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.
Detailed description
The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entacavir | Active comparator | Drug: Entacavir, Drug: TenofovirEntacavir 0.5 mg (OD) for 48 weeks |
| Tenofovir | Active comparator | Drug: Entacavir, Drug: TenofovirTenofovir 300 mg ,OD for 48 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age (18 years- 70 years)
- Hbv surface antigen positive > 6 months
- HbeAg (positive or negative both)
- Hbv DNA 10^3
- ALT ULN
Key exclusion criteria (11 listed)
- Age < 18 years
- HCC patients
- Prior drug resistance
- Current HE > 2
- Solid organ transplantation
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 |
|---|---|---|
| EntacavirAlso: ETVEntacavir-0.5 mg ,OD,for | Drug | Entacavir, Tenofovir |
| TenofovirAlso: TDF or PMPATenofovir ,300 mg,OD,for 48 weeks | Drug | Entacavir, Tenofovir |
Primary outcome
Safety and efficacy
Time frame: 48 weeks
EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.
1 secondary outcome
Safety
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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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.
Mohammad sadik Memon, Fcps gastro principal investigator
AIMS Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entacavir and Tenofovir in people with Cirrhosis Due to Hepatitis B, run by Asian Institute Of Medical Sciences at 1 site in Pakistan.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Sep 2014. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr mohammad sadik Memon, Fcps gastro (022-232593, Sadikmemon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy (time frame: 48 weeks). 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 12 Sep 2014.