Drug Induced Liver InjuryNCT02686385
Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury
A study testing Prednisolone and N-Acetylcysteine in people with Drug Induced Liver Injury, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Intervention - Subjects will be randomized to 2 groups Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine) Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Drug Induced Liver Injury
- What is being tested?
- Prednisolone and N-Acetylcysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2016to 31 Aug 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with severe DILI (Drug Induced Liver Injury)
- Age more than or equal to 18 years
Who cannot join
- Patients with HAV (Hepatitis A Virus), HBV (Hepatitis B Virus), HCV (Hepatitis C Virus), HEV (Hepatitis E Virus) Positive
- Patients with sepsis
- AMA positive
- Low Ceruloplasmin
- Transferrin saturation >45%
- Patients with Cirrhosis
- Patients with h/o jaundice prior to the intake of drug
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury: A Prospective Randomized Controlled Trial
Intervention - Subjects will be randomized to 2 groups
Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)
Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing
Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour
Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h
Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
- Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test at regular intervals.
- Stopping rule-Development of sepsis, worsening of Liver functions.
- Conditions
- Drug Induced Liver Injury
- Being tested
- Prednisolone, N-Acetylcysteine
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
N-AcetylcysteineDrug
NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone + N-Acetylcysteine | Experimental | Prednisolone for 20 days with NAC (N-Acetylcysteine) NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h Receives: Drug: Prednisolone; Drug: N-Acetylcysteine |
| N-Acetylcysteine | Active comparator | NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h Receives: Drug: N-Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with normalization of LFT (Liver Function Test) in both groups.
Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits.
Measured: 20 days
Secondary outcomes (5)
Improvement in of Histology.
Improvement is defined as decrease in inflammation, decrease in cholestasis.
Measured: 20 days
Improvement in CBC profile
Improvement is defined normalization of CBC profile.
Measured: 20 days
Improvement in coagulation profile
Improvement is defined normalization of Coagulation profile.
Measured: 20 days
Improvement in KFT profile
Improvement is defined normalization of KFT profile.
Measured: 20 days
Proportion of patients develop adverse effects in both groups.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start1 Mar 2016
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Why it stopped: Steroids were given for 2 patients who had biopsy proven Drug induced Liver Injury and both have them developed sepsis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Induced Liver InjuryStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Anand Kulkarni V, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686385
- Sponsor's protocol ID
- ILBS-DILI-001
- Status last verified
- Aug 2016
- First submitted
- 8 Feb 2016
- Last updated
- 18 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02686385
- Acronym / sponsor ID
- ILBS-DILI-001
- Conditions
- Drug Induced Liver Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Steroids were given for 2 patients who had biopsy proven Drug induced Liver Injury and both have them developed sepsis.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 19 Feb 2016 (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.
Intervention - Subjects will be randomized to 2 groups
Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)
Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing
Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour
Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h
Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
- Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test at regular intervals.
- Stopping rule-Development of sepsis, worsening of Liver functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone + N-Acetylcysteine | Experimental | Drug: Prednisolone, Drug: N-AcetylcysteinePrednisolone for 20 days with NAC (N-Acetylcysteine) NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h |
| N-Acetylcysteine | Active comparator | Drug: N-AcetylcysteineNAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with severe DILI (Drug Induced Liver Injury)
- Age more than or equal to 18 years
Key exclusion criteria (7 listed)
- Patients with HAV (Hepatitis A Virus), HBV (Hepatitis B Virus), HCV (Hepatitis C Virus), HEV (Hepatitis E Virus) Positive
- Patients with sepsis
- AMA positive
- Low Ceruloplasmin
- Transferrin saturation >45%
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 |
|---|---|---|
| Prednisolone | Drug | Prednisolone + N-Acetylcysteine |
| N-AcetylcysteineNAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h | Drug | N-Acetylcysteine, Prednisolone + N-Acetylcysteine |
Primary outcome
Proportion of patients with normalization of LFT (Liver Function Test) in both groups.
Time frame: 20 days
Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits.
5 secondary outcomes
Improvement in of Histology.
Time frame: 20 days
Improvement in CBC profile
Time frame: 20 days
Improvement in coagulation profile
Time frame: 20 days
Improvement in KFT profile
Time frame: 20 days
Proportion of patients develop adverse effects in both groups.
Time frame: 20 days
Results and safety
The study was stopped early (reason given: Steroids were given for 2 patients who had biopsy proven Drug induced Liver Injury and both have them developed sepsis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
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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.
Dr Anand Kulkarni V, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone and N-Acetylcysteine in people with Drug Induced Liver Injury, 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Dec 2017. 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 was stopped early (reason given: Steroids were given for 2 patients who had biopsy proven Drug induced Liver Injury and both have them developed sepsis.). Results are not available in the source record.
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?
Proportion of patients with normalization of LFT (Liver Function Test) in both groups. (time frame: 20 days). 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 18 Dec 2017.