AscitesPhase 2NCT01349335
Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites
A Phase 2 study testing Tolvaptan in people with Ascites and Hepatic Cirrhosis, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ascites, Hepatic Cirrhosis
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Apr 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatic cirrhosis patients after 7days treatment of loop diuretics and aldosterone antagonist but still with ascites
- Hospitalized patients or those who can be hospitalized in this trial between observation period and posttherapeutic observation (Visits at clinic will be allowed after day 8);
- During the observation period (-3 day to -1 day ), subjects whose body weight difference fall within ±1.0 kg range 2 days (day-2 and day -1) prior to initiation of trial drug treatment;
- Ages: ≥18 and ≤75 years of age;
- Genders: men or women;
- Signed the Informed Consent Form.
Who cannot join
- Patients with the following diseases, complications or symptoms:
- Hepatic encephalopathy (Coma scale Note 1) grade 2 or higher);
- Malignant ascites;
- Uncontrolled spontaneous bacterial peritonitis;
- Patients are likely to experience alimentary tract hemorrhage during the trial;
- Heart failure (NYHA cardiac function scale Note 2) stages 3 and 4);
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- Anuria (daily urine volume below 100mL);
- Dysuria resulting from urethral stricture, calculus and tumors.
- Patients with the following medical history:
- Alimentary tract hemorrhage within 10 days prior to screening;
- Cerebrovascular accident within 1 month prior to screening;
- Gout attack within 1 month prior to screening;
- Past allergy or hypersensitive reactions to benzodiazepines (e.g. benazepril hydrochloride)
- Systolic pressure below 90mmHg at screening;
- Patients with the following abnormalities in laboratory examinations at screening:
- Serum creatinine exceeds 2.5X upper limits of normal, serum Na+>145mmol/L (or exceeds upper limits of normal), serum K+>5.5mmol/L, uric acid>8.0mg/dL (476μmol/L), Child-pugh scale greater than 12.
- Patients cannot take drugs orally;
- Pregnant or breast-feeding patients or women at child-bearing ages without taking acceptable contraceptive measures;
- Patients received albumin or other blood preparations within 4 days prior to trial drug administration;
- Patients participated in clinical trials of other drugs within 1 month prior to screening;
- Patients participated in tolvaptan trials and took tolvaptan previously;
- Patients are unsuitable to participate in this trial in investigators' opinion.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200001
About this study
Official title: A Phase 2 Randomized, Double-blinded, Multicenter and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Different Doses of Tolvaptan Tablet in Patients With Cirrhotic Ascites
To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug.
Read the detailed description
Tolvaptan is able to exert hydragogue diuretic effects (water diuresis) via inhibition of water reabsorption by renal collecting ducts without corresponding increase in electrolyte excretion. It has been confirmed that tolvaptan is able to increase urine volume without any adverse effects on renal functions.
- Conditions
- Ascites, Hepatic Cirrhosis
- Being tested
- Tolvaptan, placebo
- Medical subject headings
- Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called SAMSCA
tablet, 15 mg, Qd, for 7 days
TolvaptanDrug
Also called SAMSCA
tablet, 30 mg, Qd, 7 days
placeboDrug
Also called blank tablet
tablet, 30 mg, Qd, 7days.
| Study group | Role | What they receive |
|---|---|---|
| 1. tolvaptan | Experimental | 15 mg, P.O., Qd, for 7 days, Receives: Drug: Tolvaptan |
| 2 tolvaptan | Experimental | 30 mg, P.O., Qd, for 7 days, Receives: Drug: Tolvaptan |
| 3. Placebo | Experimental | 30mg,P.O.,Qd, for 7 days. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight changes after 7 days of treatment (quantity of changes)
Measured: from day1 to day7
Secondary outcomes (2)
Body weight change after 4 days of treatment (quantity of changes)
Measured: from day1 to day4
Waist circumference after 4 and 7 days of treatment (quantity and rate of changes)
Measured: from day1 to day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionApr 2010
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 AscitesStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minde Zeng, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349335
- Sponsor's protocol ID
- 156-08-804-01
- Status last verified
- May 2011
- First submitted
- 5 Mar 2010
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang S, Zhang X, Han T, Xie W, Li Y, Ma H, Liebe R, Weng H, Ding HG. Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia. BMC Gastroenterol. 2018 Sep 4;18(1):137. doi: 10.1186/s12876-018-0857-0.
PubMed 30180806
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-blinded, Multicenter and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Different Doses of Tolvaptan Tablet in Patients With Cirrhotic Ascites
- ClinicalTrials.gov ID
- NCT01349335
- Acronym / sponsor ID
- 156-08-804-01
- Conditions
- Ascites, Hepatic Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 May 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.
To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug.
Detailed description
Tolvaptan is able to exert hydragogue diuretic effects (water diuresis) via inhibition of water reabsorption by renal collecting ducts without corresponding increase in electrolyte excretion. It has been confirmed that tolvaptan is able to increase urine volume without any adverse effects on renal functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. tolvaptan | Experimental | Drug: Tolvaptan15 mg, P.O., Qd, for 7 days, |
| 2 tolvaptan | Experimental | Drug: Tolvaptan30 mg, P.O., Qd, for 7 days, |
| 3. Placebo | Experimental | Drug: placebo30mg,P.O.,Qd, for 7 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- hepatic cirrhosis patients after 7days treatment of loop diuretics and aldosterone antagonist but still with ascites
- Hospitalized patients or those who can be hospitalized in this trial between observation period and posttherapeutic observation (Visits at clinic will be allowed after day 8);
- During the observation period (-3 day to -1 day ), subjects whose body weight difference fall within ±1.0 kg range 2 days (day-2 and day -1) prior to initiation of trial drug treatment;
- Ages: ≥18 and ≤75 years of age;
- Genders: men or women;
Key exclusion criteria (22 listed)
- Patients with the following diseases, complications or symptoms:
- Patients with the following medical history:
- Systolic pressure below 90mmHg at screening;
- Patients with the following abnormalities in laboratory examinations at screening:
- Serum creatinine exceeds 2.5X upper limits of normal, serum Na+>145mmol/L (or exceeds upper limits of normal), serum K+>5.5mmol/L, uric acid>8.0mg/dL (476μmol/L), Child-pugh scale greater than 12.
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 |
|---|---|---|
| TolvaptanAlso: SAMSCAtablet, 15 mg, Qd, for 7 days | Drug | 1. tolvaptan |
| TolvaptanAlso: SAMSCAtablet, 30 mg, Qd, 7 days | Drug | 2 tolvaptan |
| placeboAlso: blank tablettablet, 30 mg, Qd, 7days. | Drug | 3. Placebo |
Primary outcome
Body weight changes after 7 days of treatment (quantity of changes)
Time frame: from day1 to day7
2 secondary outcomes
Body weight change after 4 days of treatment (quantity of changes)
Time frame: from day1 to day4
Waist circumference after 4 and 7 days of treatment (quantity and rate of changes)
Time frame: from day1 to day7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Derived from this study: PubMed 30180806Wang S, Zhang X, Han T, Xie W, Li Y, Ma H, Liebe R, Weng H, Ding HG. Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia. BMC Gastroenterol. 2018 Sep 4;18(1):137. doi: 10.1186/s12876-018-0857-0.
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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.
Minde Zeng principal investigator
RenJi Hospital
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 Tolvaptan in people with Ascites and Hepatic Cirrhosis, run by Otsuka Beijing Research Institute at 1 site in China.
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 22 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: finished, as of the sponsor's last update on 12 Oct 2012. 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 China. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body weight changes after 7 days of treatment (quantity of changes) (time frame: from day1 to day7). 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 NCT01349335, 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 2012.