Portal HypertensionPhase 2NCT00414869
Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
A Phase 2 study testing NCX-1000 in people with Portal Hypertension, run by Forest Laboratories at 1 site in Spain.
Trial summary
Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance. It has become well established that nitric oxide (NO) plays a crucial role in the haemodynamic abnormalities that develop in chronic portal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- NCX-1000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2005to Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female patients of at least 18 years old
- HVPG > 12 mm Hg in fasting state on Day 1
- Free of any other condition (except liver failure) that may alter absorption, distribution, or elimination of drugs
Who cannot join
- Oesophageal bleeding in the previous 30 days
- Known intolerance to ursodeoxycholic acid or nitrates
- Liver cancer or liver metastasis from another cancer
- Portal hypertension secondary to venous thrombosis
- Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Severe liver failure (Child-Pugh C)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study
Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance. It has become well established that nitric oxide (NO) plays a crucial role in the haemodynamic abnormalities that develop in chronic portal hypertension.
NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis.
This study intends to demonstrate the desired therapeutic activity (reduction in portal pressure) in a small number of target patients, to assess the safety and tolerability after repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in this population.
Read the detailed description
Brief summary is complete. Study is closed.
- Conditions
- Portal Hypertension
- Being tested
- NCX-1000, Placebo
- Keywords
- Liver, Portal pressure, Fibrosis, Nitric oxide
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCX-1000Drug
500 mg powder sachets to be taken as 1, 2, or 4 sachets twice daily, PO x 16 days
PlaceboDrug
Inactive powder matching NCX-1000
| Study group | Role | What they receive |
|---|---|---|
| NCX-1000 | Experimental | Experimental drug under evaluation Receives: Drug: NCX-1000 |
| Placebo | Placebo comparator | Placebo powder Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hepatic Venous Pressure Gradient (HVPG) will be evaluated at entry (Day 1) and after the Maximal Tolerated Dose (MTD) on Day 16, in fasting and post-prandial (after a standardized liquid breakfast) states.
The portal pressure, as determined by HVPG, was obtained by subtracting the free hepatic venous pressure from the wedged hepatic venous pressure and rounded to the nearest 0.5 or integer value.The pressures were recorded 3 times for each evaluation and the HVPG value was the mean of the 3 Recordings
Measured: Day1 and Day 16
Secondary outcomes (2)
Safety parameters: systolic and diastolic blood pressures, heart rate, physical examination, laboratory tests and Adverse Events (AEs)
Usual safety parameters. Blood pressures were assessed every 30 minutes for 4 hours after drug intake. Other parameters were assessed or reported at Study visits
Measured: At various times
Plasma levels of NCX-1000 and its main metabolites will be evaluated to get preliminary pharmacokinetic data.
Usual pharmacokinetic (PK) evaluation
Measured: 0, 1, 2, 3, and 4 hours after the first 3 doses anf after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startNov 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Preliminary analysis of 11 patients did not demonstrate the efficacy required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Bosch, MD, Principal investigator, Clinic Barcelona Hospital Universatiri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414869
- Sponsor's protocol ID
- NCXDE05-02
- Status last verified
- Feb 2017
- First submitted
- 21 Dec 2006
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study
- ClinicalTrials.gov ID
- NCT00414869
- Acronym / sponsor ID
- NCXDE05-02
- Conditions
- Portal Hypertension
- Keywords
- Liver, Portal pressure, Fibrosis, Nitric oxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary analysis of 11 patients did not demonstrate the efficacy required.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 22 Dec 2006 (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.
Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance. It has become well established that nitric oxide (NO) plays a crucial role in the haemodynamic abnormalities that develop in chronic portal hypertension.
NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis.
This study intends to demonstrate the desired therapeutic activity (reduction in portal pressure) in a small number of target patients, to assess the safety and tolerability after repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in this population.
Detailed description
Brief summary is complete. Study is closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCX-1000 | Experimental | Drug: NCX-1000Experimental drug under evaluation |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo powder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or non-pregnant female patients of at least 18 years old
- HVPG > 12 mm Hg in fasting state on Day 1
- Free of any other condition (except liver failure) that may alter absorption, distribution, or elimination of drugs
Key exclusion criteria (6 listed)
- Oesophageal bleeding in the previous 30 days
- Known intolerance to ursodeoxycholic acid or nitrates
- Liver cancer or liver metastasis from another cancer
- Portal hypertension secondary to venous thrombosis
- Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
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 |
|---|---|---|
| NCX-1000500 mg powder sachets to be taken as 1, 2, or 4 sachets twice daily, PO x 16 days | Drug | NCX-1000 |
| PlaceboInactive powder matching NCX-1000 | Drug | Placebo |
Primary outcome
The Hepatic Venous Pressure Gradient (HVPG) will be evaluated at entry (Day 1) and after the Maximal Tolerated Dose (MTD) on Day 16, in fasting and post-prandial (after a standardized liquid breakfast) states.
Time frame: Day1 and Day 16
The portal pressure, as determined by HVPG, was obtained by subtracting the free hepatic venous pressure from the wedged hepatic venous pressure and rounded to the nearest 0.5 or integer value.The pressures were recorded 3 times for each evaluation and the HVPG value was the mean of the 3 Recordings
2 secondary outcomes
Safety parameters: systolic and diastolic blood pressures, heart rate, physical examination, laboratory tests and Adverse Events (AEs)
Time frame: At various times
Plasma levels of NCX-1000 and its main metabolites will be evaluated to get preliminary pharmacokinetic data.
Time frame: 0, 1, 2, 3, and 4 hours after the first 3 doses anf after the last dose
Results and safety
The study was stopped early (reason given: Preliminary analysis of 11 patients did not demonstrate the efficacy required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
Jaime Bosch, MD principal investigator
Clinic Barcelona Hospital Universatiri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NCX-1000 in people with Portal Hypertension, run by Forest Laboratories at 1 site in Spain.
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 6 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 9 Feb 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 Spain. 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?
The study was stopped early (reason given: Preliminary analysis of 11 patients did not demonstrate the efficacy required.). 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?
The Hepatic Venous Pressure Gradient (HVPG) will be evaluated at entry (Day 1) and after the Maximal Tolerated Dose (MTD) on Day 16, in fasting and post-prandial (after a standardized liquid breakfast) states. (time frame: Day1 and Day 16). 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 9 Feb 2017.