Acute on Chronic Hepatic FailurePhase 2HEVRibavirinNCT01698723
A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus
A Phase 2 study testing Ribavirin in people with Acute on Chronic Hepatic Failure and Liver Failure, run by All India Institute of Medical Sciences at 2 sites in India.
Trial summary
The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis E Infection
- What is being tested?
- Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesIndia
- Study dates
- Sep 2012to Jun 2016
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All ACLF due to HEV
- Consent to participate in trial and collection of blood.
Who cannot join
- Pregnant and nursing mothers.
- Severe anemia
- Other etiologies of ACLF (eg. Alcohol, drugs, reactivation of hepatitis B and hepatitis C, variceal bleeding, surgical intervention and sepsis)
- Hepatocellular carcinoma (HCC)
- Hepatorenal syndrome (HRS) at admission
- Presence of life threatening cardiovascular, respiratory and neurological disease
Show all 9Show fewer
- Acquired Immunodeficiency Syndrome
- Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
- Refusal to provide consent to participate in the study
Trial locations and contacts
2 sites in 1 country.
Shalimar ., DM contact
India2 sites, 2 recruiting
- Recruiting
AII India Institute of Medical Sciences
Delhi, National Capital Territory of Delhi, 110029
Subrat K Acharya, DM, +91-11-26594934, subratacharya2004@yahoo.com
Shalimar ., DM, +91-9968405815, drshalimar@yahoo.com
- Recruiting
All India Institute of Medical Sciences
Delhi, National Capital Territory of Delhi, 110029
Subrat K Acharya, DM, +91-11-26594934, subratacharya2004@yahoo.com
Shalimar ., DM, +91-9968405815, drshalimar@yahoo.com
About this study
Official title: A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus
The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. In this condition two insults act simultaneously, one being the preexisting liver injury (chronic liver disease) and the other acute injury which is responsible for the acute decompensation. HEV being a major factor responsible for this clinical entity and has a very high mortality rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can be an important drug in the treatment of these patients. Therefore the present study is designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.
- Being tested
- Ribavirin, Placebo
- Keywords
- ACLF, HEV, Ribavirin
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ribavirin | Active comparator | 1000 mg (5 capsules) Receives: Drug: Ribavirin |
| Placebo | Placebo comparator | 5 capsules of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in survival
Measured: 4 weeks and 12 moths
Secondary outcomes (3)
Child Score
Change in Child Score will be evaluated at every 4 week interval
Measured: 4 weeks and 12 months
Viremia
Change in viral load
Measured: 4 weeks, 3 months
Variceal bleeding
Variceal bleeding will be assessed every 4 weeks
Measured: 4 weeks and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Hepatic FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subrat Kumar Acharya, All India Institute of Medical Sciences
- Investigators
- Subrat K Acharya, DM, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698723
- Sponsor's protocol ID
- HEV-RIBA
- Acronym
- HEVRibavirin
- Status last verified
- Apr 2016
- First submitted
- 27 Sep 2012
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus
- ClinicalTrials.gov ID
- NCT01698723
- Acronym / sponsor ID
- HEVRibavirin / HEV-RIBA
- Keywords
- ACLF, HEV, Ribavirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 3 Oct 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 term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. In this condition two insults act simultaneously, one being the preexisting liver injury (chronic liver disease) and the other acute injury which is responsible for the acute decompensation. HEV being a major factor responsible for this clinical entity and has a very high mortality rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can be an important drug in the treatment of these patients. Therefore the present study is designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribavirin | Active comparator | Drug: Ribavirin1000 mg (5 capsules) |
| Placebo | Placebo comparator | Drug: Placebo5 capsules of placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All ACLF due to HEV
- Consent to participate in trial and collection of blood.
Key exclusion criteria (9 listed)
- Pregnant and nursing mothers.
- Severe anemia
- Other etiologies of ACLF (eg. Alcohol, drugs, reactivation of hepatitis B and hepatitis C, variceal bleeding, surgical intervention and sepsis)
- Hepatocellular carcinoma (HCC)
- Hepatorenal syndrome (HRS) at admission
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 |
|---|---|---|
| Ribavirin | Drug | Ribavirin |
| Placebo | Drug | Placebo |
Primary outcome
Improvement in survival
Time frame: 4 weeks and 12 moths
3 secondary outcomes
Child Score
Time frame: 4 weeks and 12 months
Viremia
Time frame: 4 weeks, 3 months
Variceal bleeding
Time frame: 4 weeks and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Individual participant dataSharing planned: Yes
Related trials for Acute on Chronic Hepatic Failure
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
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.
Shalimar ., DM contact
Subrat K Acharya, DM principal investigator
All India Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ribavirin in people with Acute on Chronic Hepatic Failure and Liver Failure, run by All India Institute of Medical Sciences at 2 sites 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 2 inclusion and 9 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Subrat K Acharya, DM (+91-11-26594934, subratacharya2004@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in survival (time frame: 4 weeks and 12 moths). 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 26 Apr 2016.