Non Alcoholic SteatohepatitisPhase 3NCT01384578
Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis
A Phase 3 study testing pentoxiphylline and Vitamin E and Vitamin E in people with Non Alcoholic Steatohepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
120 patients of biopsy proven NASH will be randomized into two groups. Cases group will receive combination of pentoxiphylline and Vitamin E, and control group will receive only Vitamin E. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Alcoholic Steatohepatitis
- What is being tested?
- pentoxiphylline and Vitamin E and Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Nov 2013
- Phase
- Phase 3
- 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 to 70 years
- Persistently abnormal ALT >1.2 times upper limit of normal
- Histological evidence of NASH/cirrhosis on liver biopsy. ( The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and either ballooning of cells or perisinusoidal or pericellular fibrosis in Zone 3 of the hepatic acinus)
Who cannot join
- A known case of Type 2 diabetes mellitus on treatment
- Alcohol intake of more than 40gm / week
- If they had evidence of cirrhosis with significant portal hypertension
- Ongoing total parenteral nutrition/ jejunal-ileal bypass
- Other known liver disease (Hepatitis A to E, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis)
- Medication like estrogens, amiodarone, MTx, tamoxifen, ATT
Show all 12Show fewer
- Pregnancy or lactation
- Hypersensitivity to methylxanthines (e.g., caffeine, theophylline, theobromine )
- Recent retinal/cerebral hemorrhage
- Acute myocardial infarction or severe cardiac arrhythmias
- Impaired renal function
- Hypothyroidism
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: A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis
120 patients of biopsy proven NASH will be randomized into two groups. Cases group will receive combination of pentoxiphylline and Vitamin E, and control group will receive only Vitamin E.
Read the detailed description
The investigators plan to randomise 120 patients of biopsy proven NASH into cases and control groups.
Baseline investigations:
Clinical characteristics
- Age
- Gender
- Anthropometry (BMI, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference)
- Alcohol intake should be nil
Laboratory characteristics
- Hemogram, INR, KFT
- LFT (especially ALT, GGT) , APRI (AST to platelet ratio)
- Fasting Lipid Profile
- Other possible etiologies of liver disease (viral markers, ferritin, ANA, IgG, ceruloplasmin )
- HOMA-IR (II)
- Serum uric acid levels Liver stiffness
- Fibroscan
- MR elastography Radiological characteristics
- USG abdomen Variceal status by UGI endoscopy Alpha fetoprotein Pro- inflammatory markers
- TNF-alpha, IL-6, adiponectin, leptin and osteopontin Liver biopsy and NAS score
- Conditions
- Non Alcoholic Steatohepatitis
- Being tested
- pentoxiphylline and Vitamin E, Vitamin E
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentoxiphylline and Vitamin EDrug
Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day.
Vitamin EDrug
Patients in control group will receive vitamin E 800 IU/day
| Study group | Role | What they receive |
|---|---|---|
| pentoxiphylline and Vitamin E | Experimental | Not described Receives: Drug: pentoxiphylline and Vitamin E |
| Vitamin E | Active comparator | Not described Receives: Drug: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).
Measured: 3 Months
Secondary outcomes (1)
Response in form of anthropometry , HOMA-IR, fasting lipid profiles, biochemical response in form of normalization of ALT and AST levels and reduction in uric
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic SteatohepatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 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, MD,DM, Study director, Institute of Liver & Biliary Sciences (ILBS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384578
- Sponsor's protocol ID
- ILBS-NASH-02
- Status last verified
- Jul 2012
- First submitted
- 28 Jun 2011
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kedarisetty CK, Bhardwaj A, Kumar G, Rastogi A, Bihari C, Kumar M, Sarin SK. Efficacy of combining pentoxiphylline and vitamin E versus vitamin E alone in non-alcoholic steatohepatitis- A randomized pilot study. Indian J Gastroenterol. 2021 Feb;40(1):41-49. doi: 10.1007/s12664-020-01131-x. Epub 2021 Mar 27.
PubMed 33772456
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT01384578
- Acronym / sponsor ID
- ILBS-NASH-02
- Conditions
- Non Alcoholic Steatohepatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 29 Jun 2011 (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.
120 patients of biopsy proven NASH will be randomized into two groups. Cases group will receive combination of pentoxiphylline and Vitamin E, and control group will receive only Vitamin E.
Detailed description
The investigators plan to randomise 120 patients of biopsy proven NASH into cases and control groups.
Baseline investigations:
Clinical characteristics
- Age
- Gender
- Anthropometry (BMI, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference)
- Alcohol intake should be nil
Laboratory characteristics
- Hemogram, INR, KFT
- LFT (especially ALT, GGT) , APRI (AST to platelet ratio)
- Fasting Lipid Profile
- Other possible etiologies of liver disease (viral markers, ferritin, ANA, IgG, ceruloplasmin )
- HOMA-IR (II)
- Serum uric acid levels Liver stiffness
- Fibroscan
- MR elastography Radiological characteristics
- USG abdomen Variceal status by UGI endoscopy Alpha fetoprotein Pro- inflammatory markers
- TNF-alpha, IL-6, adiponectin, leptin and osteopontin Liver biopsy and NAS score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pentoxiphylline and Vitamin E | Experimental | Drug: pentoxiphylline and Vitamin E |
| Vitamin E | Active comparator | Drug: Vitamin E |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 70 years
- Persistently abnormal ALT >1.2 times upper limit of normal
- Histological evidence of NASH/cirrhosis on liver biopsy. ( The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and either ballooning of cells or perisinusoidal or pericellular fibrosis in Zone 3 of the hepatic acinus)
Key exclusion criteria (12 listed)
- A known case of Type 2 diabetes mellitus on treatment
- Alcohol intake of more than 40gm / week
- If they had evidence of cirrhosis with significant portal hypertension
- Ongoing total parenteral nutrition/ jejunal-ileal bypass
- Other known liver disease (Hepatitis A to E, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis)
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 |
|---|---|---|
| pentoxiphylline and Vitamin EPatients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day. | Drug | pentoxiphylline and Vitamin E |
| Vitamin EPatients in control group will receive vitamin E 800 IU/day | Drug | Vitamin E |
Primary outcome
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).
Time frame: 3 Months
1 secondary outcome
Response in form of anthropometry , HOMA-IR, fasting lipid profiles, biochemical response in form of normalization of ALT and AST levels and reduction in uric
Time frame: 3 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 33772456Kedarisetty CK, Bhardwaj A, Kumar G, Rastogi A, Bihari C, Kumar M, Sarin SK. Efficacy of combining pentoxiphylline and vitamin E versus vitamin E alone in non-alcoholic steatohepatitis- A randomized pilot study. Indian J Gastroenterol. 2021 Feb;40(1):41-49. doi: 10.1007/s12664-020-01131-x. Epub 2021 Mar 27.
Related trials for Non Alcoholic Steatohepatitis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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, MD,DM study director
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 Phase 3 study testing pentoxiphylline and Vitamin E and Vitamin E in people with Non Alcoholic Steatohepatitis, 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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 12 Oct 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score). (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384578, which also lists 1 linked publication.
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 Oct 2015.