Hepatic Encephalopathy.Phase 1/2NCT02028429
Efficacy of Sildenafil in the Improvement of Cognition and Quality of Life in Patients With Cirrhosis of Liver. A Proof of Concept Study.
A Phase 1/2 study testing Sildenafil. in people with Hepatic Encephalopathy., run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal hepatic encephalopathy (MHE) as proposed in different studies. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hepatic Encephalopathy.
- What is being tested?
- Sildenafil.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2012to Jan 2014
- Phase
- Phase 1/2
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients unable to give informed consent.
- H/O alcohol intake during last 12 weeks.
- Significant comorbid illness such as heart disease, respiratory disease, or renal failure.
- Any neurological disease such as Alzheimer disease, Parkinson's disease, stroke, non- hepatic metabolic encephalopathy's.
- Any anatomical deformities or disease of the penis such as Peyronie's disease.
- Patients having psychiatric illness and taking treatment with antidepressant, sedative or neuroleptics.
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- Patients who start taking alcohol during the study period will be excluded.
- Patients taking vasodilators such as nitrates.
- Hepatocellular carcinoma.
- Recent history of upper GI bleed in last 6 weeks.
- Active ongoing infection.
- Electrolyte abnormality precipitating MHE.
- Color vision abnormalities.
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education & Research Chandigarh
Chandigarh, Chandigarh, 160012
About this study
Official title: To Study The Proof of Concept in The Improvement of Cognition and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy by Means of a Pharmacological Intervention With Sildenafil (A Phosphodiesterase-5 Inhibitor).
The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal hepatic encephalopathy (MHE) as proposed in different studies.
This study would also assess the role of improvement of cognition as a means of improvement in quality of life.The patients will receive Sildenafil or no treatment for 4 weeks.
This study may prove and provide important therapeutic strategy for cognition impairment in patients with MHE.
Read the detailed description
Primary Aim
- To study the proof of concept in the improvement of impairment in cognition as assessed by PHES (psychometric hepatic encephalopathy score) in patients of MHE by means of pharmacological intervention by Sildenafil (a phosphodiesterase(PDE)-5 inhibitor) before and after treatment.
- To study the impact of treatment with Sildenafil administration on the improvement in health-related quality-of-life of patients as assessed by Sickness impact profile (SIP) before and after treatment.
Secondary Aim
- To study the impact of treatment with Sildenafil on CTP and MELD scores before and after treatment.
- To study the impact of treatment with Sildenafil on blood ammonia and Interleukin-6 levels before and after treatment.
Study Population: The study population comprises of male adult (age 18-70 years) with cirrhosis of liver. Patients with cirrhosis of liver have been divided into two groups - with MHE and without or no MHE (NMHE) based on the test result of PHES, i.e., abnormal (MHE group) or normal (NMHE group).
Inclusion Criteria:
- Male patients aged 18-70 years diagnosed to have cirrhosis of liver at Liver Clinic of Department of Hepatology, Postgraduate Institute of Medical Education \& Research(PGIMER), Chandigarh by means of clinical, biochemical and ultrasonographical/CT or liver biopsy.
- MHE will be defined by PHES ≤-5 and normal Mini-Mental State Examination (MMSE) score of ≥24.
Exclusion Criteria:
- Patients unable to give informed consent.
- H/O alcohol intake during last 12 weeks.
- Significant comorbid illness such as heart disease, respiratory disease, or renal failure.
- Any neurological disease such as Alzheimer disease, Parkinson's disease, stroke, non- hepatic metabolic encephalopathy's.
- Any anatomical deformities or disease of the penis such as Peyronie's disease.
- Patients having psychiatric illness and taking treatment with antidepressant, sedative or neuroleptics.
- Patients who start taking alcohol during the study period will be excluded.
- Patients taking vasodilators such as nitrates.
- Hepatocellular carcinoma.
- Recent history of upper GI bleed in last 6 weeks.
- Active ongoing infection.
- Electrolyte abnormality precipitating MHE.
- Color vision abnormalities.
- Conditions
- Hepatic Encephalopathy.
- Being tested
- Sildenafil.
- Keywords
- Minimal Hepatic Encephalopathy (MHE), Psychometric Hepatic Encephalopathy Score (PHES), Sickness Impact Profile (SIP), Model for End-stage Liver Disease (MELD), Child-Turcotte-Pugh score (CTP)
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil.Drug
Also called Suhagra.
Arm 1 :Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 'Sildenafil'. | Experimental | MHE patient receiving Sildenafil. Intervention: Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week. Receives: Drug: Sildenafil. |
| 'No sildenafil' | No intervention | Control Arm: MHE patients not receiving SIldenafil Intervention.Followed up for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition( PHES)
Improvement of impairment in cognition as assessed by PHES (Psychometric Hepatic Encephalopathy Score) in patients of MHE (Minimal hepatic Encephalopathy) by means of pharmacological intervention by sildenafil (a PDE-5 inhibitor) before and after treatment.
Measured: 4 weeks
QOL(SIP)
To study the impact of treatment with sildenafil administration on the improvement in health-related quality-of-life of patients as assessed by sickness impact profile (SIP) before and after treatment.
Measured: 4 weeks
Secondary outcomes (2)
CTP and MELD score before and after treatment with Sildenafil.
To study the impact of treatment with sildenafil on CTP and MELD scores before and after treatment.
Measured: 4 weeks
Blood Ammonia and Interleukin-6 levels before and after treatment with Sildenafil.
Blood Ammonia and Interleukin-6 levels before and after treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJul 2012
- Primary completionNov 2013
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Encephalopathy.Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radha K Dhiman, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Radha K Dhiman, MD, DM, FACG, Principal investigator, PGIMER Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028429
- Sponsor's protocol ID
- Hepatology PGIMER 2012
- Status last verified
- Jan 2014
- First submitted
- 28 Dec 2013
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study The Proof of Concept in The Improvement of Cognition and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy by Means of a Pharmacological Intervention With Sildenafil (A Phosphodiesterase-5 Inhibitor).
- ClinicalTrials.gov ID
- NCT02028429
- Acronym / sponsor ID
- Hepatology PGIMER 2012
- Conditions
- Hepatic Encephalopathy.
- Keywords
- Minimal Hepatic Encephalopathy (MHE), Psychometric Hepatic Encephalopathy Score (PHES), Sickness Impact Profile (SIP), Model for End-stage Liver Disease (MELD), Child-Turcotte-Pugh score (CTP)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (estimated)
- First posted
- 7 Jan 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.
The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal hepatic encephalopathy (MHE) as proposed in different studies.
This study would also assess the role of improvement of cognition as a means of improvement in quality of life.The patients will receive Sildenafil or no treatment for 4 weeks.
This study may prove and provide important therapeutic strategy for cognition impairment in patients with MHE.
Detailed description
Primary Aim
- To study the proof of concept in the improvement of impairment in cognition as assessed by PHES (psychometric hepatic encephalopathy score) in patients of MHE by means of pharmacological intervention by Sildenafil (a phosphodiesterase(PDE)-5 inhibitor) before and after treatment.
- To study the impact of treatment with Sildenafil administration on the improvement in health-related quality-of-life of patients as assessed by Sickness impact profile (SIP) before and after treatment.
Secondary Aim
- To study the impact of treatment with Sildenafil on CTP and MELD scores before and after treatment.
- To study the impact of treatment with Sildenafil on blood ammonia and Interleukin-6 levels before and after treatment.
Study Population: The study population comprises of male adult (age 18-70 years) with cirrhosis of liver. Patients with cirrhosis of liver have been divided into two groups - with MHE and without or no MHE (NMHE) based on the test result of PHES, i.e., abnormal (MHE group) or normal (NMHE group).
Inclusion Criteria:
- Male patients aged 18-70 years diagnosed to have cirrhosis of liver at Liver Clinic of Department of Hepatology, Postgraduate Institute of Medical Education \& Research(PGIMER), Chandigarh by means of clinical, biochemical and ultrasonographical/CT or liver biopsy.
- MHE will be defined by PHES ≤-5 and normal Mini-Mental State Examination (MMSE) score of ≥24.
Exclusion Criteria:
- Patients unable to give informed consent.
- H/O alcohol intake during last 12 weeks.
- Significant comorbid illness such as heart disease, respiratory disease, or renal failure.
- Any neurological disease such as Alzheimer disease, Parkinson's disease, stroke, non- hepatic metabolic encephalopathy's.
- Any anatomical deformities or disease of the penis such as Peyronie's disease.
- Patients having psychiatric illness and taking treatment with antidepressant, sedative or neuroleptics.
- Patients who start taking alcohol during the study period will be excluded.
- Patients taking vasodilators such as nitrates.
- Hepatocellular carcinoma.
- Recent history of upper GI bleed in last 6 weeks.
- Active ongoing infection.
- Electrolyte abnormality precipitating MHE.
- Color vision abnormalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention 'Sildenafil'. | Experimental | Drug: Sildenafil.MHE patient receiving Sildenafil. Intervention: Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week. |
| 'No sildenafil' | No intervention | –Control Arm: MHE patients not receiving SIldenafil Intervention.Followed up for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Patients unable to give informed consent.
- H/O alcohol intake during last 12 weeks.
- Significant comorbid illness such as heart disease, respiratory disease, or renal failure.
- Any neurological disease such as Alzheimer disease, Parkinson's disease, stroke, non- hepatic metabolic encephalopathy's.
- Any anatomical deformities or disease of the penis such as Peyronie's disease.
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 |
|---|---|---|
| Sildenafil.Also: Suhagra.Arm 1 :Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week. | Drug | Intervention 'Sildenafil'. |
Primary outcome
Cognition( PHES)
Time frame: 4 weeks
Improvement of impairment in cognition as assessed by PHES (Psychometric Hepatic Encephalopathy Score) in patients of MHE (Minimal hepatic Encephalopathy) by means of pharmacological intervention by sildenafil (a PDE-5 inhibitor) before and after treatment.
QOL(SIP)
Time frame: 4 weeks
To study the impact of treatment with sildenafil administration on the improvement in health-related quality-of-life of patients as assessed by sickness impact profile (SIP) before and after treatment.
2 secondary outcomes
CTP and MELD score before and after treatment with Sildenafil.
Time frame: 4 weeks
Blood Ammonia and Interleukin-6 levels before and after treatment with Sildenafil.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 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.
Radha K Dhiman, MD, DM, FACG principal investigator
PGIMER Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sildenafil. in people with Hepatic Encephalopathy., run by Post Graduate Institute of Medical Education and Research, Chandigarh 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 0 inclusion and 13 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 7 Jan 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Cognition( PHES) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 7 Jan 2014.