Non-alcoholic Fatty Liver DiseasePhase 2Hepar-PNCT01680003
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease
A Phase 2 study testing Hepar-P in people with Non-alcoholic Fatty Liver Disease, run by Nova Laboratories Sdn Bhd at 5 sites in Malaysia.
Trial summary
This is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a treatment period of 48 weeks Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Hepar-P
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 5 sitesMalaysia
- Study dates
- Sep 2012to Dec 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant females age 18 years or older
- Written informed consent obtained from patient or parents/ guardian
- Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5times the upper limit of the normal range
- Patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial
- Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with activity score ≥5
- A score of at least 1 for hepatocellular ballooning
Who cannot join
- Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test
- Participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study
- Those persons directly involved in the conduct of the study
- Alcohol consumption of more than 20g per day for women or more than 30g per day for men for at least 3 consecutive months during the previous 5 years, as assessed with the use of the Lifetime Drinking History questionnaire and the interview version of the Alcohol Use and Disorders Identification Test (AUDIT)
- History of cirrhosis, hepatitis C or other liver diseases
- History of heart failure (New York Association Class II to IV)
- History of taking medications known to cause steatohepatitis
- Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Malaysia5 sites, 5 recruiting
- Recruiting
Sultamah Bahiyah Hospital
Alor Star, Kedah, 05460
Muhammad Radzi Abu Hassan, Dr, +604-7407814, drradzi91@yahoo.co.uk
Muhammad Radzi Abu Hassan, Dr
- Recruiting
Queen Elizaberth Hospital
Kota Kinabalu, Sabah, 88586
Jayaram Menon, Dr, +(6)088-517555 ext. 7117, drmjayaram@gmail.com
Jayaram Menon, Dr
- Recruiting
Ampang Hospital
Kuala Selangor, Selangor, 68000
Rosaida Mohd Said, Dr, 03-42896155, drrosaida@moh.gov.my
Rosaida Mohd Said, Dr
- Recruiting
Tengku Ampuan Afzan Hospital
Kuantan, Pahang, 25100
Tee Hoi Poh, Dr, 09-5133334, hptee@hotmail.com
Tee Hoi Poh, Dr
- Recruiting
Kuala Lumpur Hospital
Wilayah Persekutuan, Kuala Lumpur, 50586
Shashi Kumar Kumar Bhaskaran, Dr, 03-26155555 ext. 5691, dr_shashi@hotmail.com
Shashi Kumar Menon Bhaskaran, Dr
About this study
Official title: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of HEPAR-P Capsule for the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD)
This is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a treatment period of 48 weeks
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Hepar-P, Placebo for Hepar-P
- 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.
Hepar-PDrug
Placebo for Hepar-PDrug
| Study group | Role | What they receive |
|---|---|---|
| Hepar-P | Experimental | Hepar-P: Two capsules (250mg x 2), three times daily, orally Receives: Drug: Hepar-P |
| Placebo for Hepar-P | Placebo comparator | Placebo: Two capsules, three times daily, orally Receives: Drug: Placebo for Hepar-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in serum aspartate aminotransferase and alanine aminotransferase levels
Measured: 48 weeks
Secondary outcomes (1)
Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score
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 posted6 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Laboratories Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muhammad Radzi Abu Hassan, Dr, Principal investigator, Sultanah Bahiyah Hospital, Alor StarTan Soek Siam, Dr, Principal investigator, Selayang Hospital, SelangorTee Hoi Poh, Dr, Principal investigator, Tengku Ampuau Afzan Hospital, KuantanRosaida Mohd Said, Dr, Principal investigator, Ampang Hospital, SelangorShashi Kumar Bhaskaran, Dr, Principal investigator, Kuala Lumpur HospitalJayaram Menon, Dr, Principal investigator, Queen Elizaberth Hospital, Sabah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680003
- Sponsor's protocol ID
- CT11-03
- Acronym
- Hepar-P
- Status last verified
- Apr 2013
- First submitted
- 3 Sep 2012
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of HEPAR-P Capsule for the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT01680003
- Acronym / sponsor ID
- Hepar-P / CT11-03
- Conditions
- Non-alcoholic Fatty Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nova Laboratories Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Sep 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.
This is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a treatment period of 48 weeks
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 |
|---|---|---|
| Hepar-P | Experimental | Drug: Hepar-PHepar-P: Two capsules (250mg x 2), three times daily, orally |
| Placebo for Hepar-P | Placebo comparator | Drug: Placebo for Hepar-PPlacebo: Two capsules, three times daily, orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant females age 18 years or older
- Written informed consent obtained from patient or parents/ guardian
- Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5times the upper limit of the normal range
- Patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial
- Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with activity score ≥5
Key exclusion criteria (8 listed)
- Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test
- Participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study
- Those persons directly involved in the conduct of the study
- Alcohol consumption of more than 20g per day for women or more than 30g per day for men for at least 3 consecutive months during the previous 5 years, as assessed with the use of the Lifetime Drinking History questionnaire and the interview version of the Alcohol Use and Disorders Identification Test (AUDIT)
- History of cirrhosis, hepatitis C or other liver diseases
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 |
|---|---|---|
| Hepar-P | Drug | Hepar-P |
| Placebo for Hepar-P | Drug | Placebo for Hepar-P |
Primary outcome
Improvement in serum aspartate aminotransferase and alanine aminotransferase levels
Time frame: 48 weeks
1 secondary outcome
Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score
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 Apr 2013.
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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.
Muhammad Radzi Abu Hassan, Dr principal investigator
Sultanah Bahiyah Hospital, Alor Star
Tan Soek Siam, Dr principal investigator
Selayang Hospital, Selangor
Tee Hoi Poh, Dr principal investigator
Tengku Ampuau Afzan Hospital, Kuantan
5 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 Hepar-P in people with Non-alcoholic Fatty Liver Disease, run by Nova Laboratories Sdn Bhd at 5 sites in Malaysia.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Malaysia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in serum aspartate aminotransferase and alanine aminotransferase levels (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 Apr 2013.