Hepatic CirrhosisPhase 1NCT01359462
Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
A Phase 1 study testing tolvaptan in people with Hepatic Cirrhosis and Ascites, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Cirrhosis, Ascites
- What is being tested?
- tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Jan 2010
- Phase
- Phase 1
- 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 with ascites or lower extremities edema
- Hospitalized patients
- 18 years old~75 years old
- Inform Consent Form Signed
Who cannot join
- Patients with any of the following diseases, complications or symptoms:
- Hepatic encephalopathy (coma degree classification note 1 Grade 2 or above);
- Malignant ascites;
- Spontaneous bacterial peritonitis;
- Likely to have gastrointestinal bleeding during the study period;
- Heart failure (NYHA Note 2 Class Ⅲ andⅣ);
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- Anuria (daily urine output below 100mL);
- Dysuria induced by urinary tract stenosis, calculus, or tumor.
- Patients with any of the following history:
- With gastrointestinal bleeding within 10 days prior to screening;
- With cerebrovascular accident within 1 month prior to screening;
- With gout attack within 1 month prior to screening;
- With allergy or atopy to benzodiazepine drugs (benazepril hydrochloride, etc.).
- Patients whose systolic blood pressure is below 90mmHg during screening;
- Patients with abnormal values in the following lab examination indicators:
- Serum creatinine higher than 2.5 times the upper limit of normal range, serum Na+>145mmol/L(or higher than the upper limit of normal range), serum K+> 5.5 mmol/L, uric acid>476µmol/L, child-Pugh score>10
- Patients ineligible for oral medication
- Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;
- Patients having taken blood products including albumin products within 4 days prior to application of investigational product;
- Patients having participated in clinical trials of other drugs within 1 month prior to screening;
- Patients used to participate in clinical trials of Tolvaptan and take the said drug;
- Patients determined by the investigator as illegible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
About this study
Official title: A Clinical Study of Multiple-dose Pharmacokinetics of Tolvaptan Tablets Administered Orally (15mg Daily) for Consecutively 7 Days in Chinese Patients With Hepatocirrhosis
For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.
Read the detailed description
This study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and safety of Tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in Chinese adult patients with confirmed Child-Pugh Class B（score 7-9） hepatocirrhosis (accompanied by ascites).
Trial Design:
- Open, single-center, multi-dose pharmacokinetics study
- Study population: Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)
- Dosage and mode of administration of investigational product: Oral administration of 1 tablet (15mg) once daily, for consecutive 7 days starting from day 1 of treatment.
- Study duration:
Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day
- Conditions
- Hepatic Cirrhosis, Ascites
- Being tested
- tolvaptan
- Keywords
- hepatic cirrhosis patients with ascites
- Medical subject headings
- Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolvaptanDrug
Also called SAMSCA
Drug: tolvaptan
tablet, 15mg, Qd, for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan 15mg tablet | Experimental | Not described Receives: Drug: tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of tolvaptan and its metabolites DM-4103 and DM-4107
Measured: blood sample will be collected at predose, 2,4,6,8,12,24 hour of first drug administration and predose of sixth drug administration and predose,2,4,6,8,12,24 hour of seventh drug administration
Secondary outcomes (2)
pharmacological parameter:Serum concentration of sodium and potassium
Measured: Blood sample will be collected at predose on day1;12,24hour of first dosing;before breakfast on day3 to day6;predose and 12,24hour of seventh dosing
pharmacological parameter:24-hr urine
Measured: From day-1 to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionJan 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 Hepatic CirrhosisStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Minde Zeng, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359462
- Sponsor's protocol ID
- 156-09-806-01
- Status last verified
- May 2011
- First submitted
- 5 Mar 2010
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu H, Wang Y, Liu T, Chen Y, Zheng X, Liu M, Zhao Q, Zeng M, Jiang J, Mao Y, Hu P. Pharmacokinetics, pharmacodynamics and safety of 15 mg-tolvaptan administered orally for 7 consecutive days to Chinese patients with child-Pugh B cirrhosis. Front Pharmacol. 2024 Jan 26;15:1324299. doi: 10.3389/fphar.2024.1324299. eCollection 2024.
PubMed 38344178
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Multiple-dose Pharmacokinetics of Tolvaptan Tablets Administered Orally (15mg Daily) for Consecutively 7 Days in Chinese Patients With Hepatocirrhosis
- ClinicalTrials.gov ID
- NCT01359462
- Acronym / sponsor ID
- 156-09-806-01
- Conditions
- Hepatic Cirrhosis, Ascites
- Keywords
- hepatic cirrhosis patients with ascites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 24 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.
For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.
Detailed description
This study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and safety of Tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in Chinese adult patients with confirmed Child-Pugh Class B（score 7-9） hepatocirrhosis (accompanied by ascites).
Trial Design:
- Open, single-center, multi-dose pharmacokinetics study
- Study population: Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)
- Dosage and mode of administration of investigational product: Oral administration of 1 tablet (15mg) once daily, for consecutive 7 days starting from day 1 of treatment.
- Study duration:
Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolvaptan 15mg tablet | Experimental | Drug: tolvaptan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hepatic Cirrhosis with ascites or lower extremities edema
- Hospitalized patients
- 18 years old~75 years old
- Inform Consent Form Signed
Key exclusion criteria (22 listed)
- Patients with any of the following diseases, complications or symptoms:
- Patients with any of the following history:
- Patients whose systolic blood pressure is below 90mmHg during screening;
- Patients with abnormal values in the following lab examination indicators:
- Serum creatinine higher than 2.5 times the upper limit of normal range, serum Na+>145mmol/L(or higher than the upper limit of normal range), serum K+> 5.5 mmol/L, uric acid>476µmol/L, child-Pugh score>10
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: SAMSCADrug: tolvaptan tablet, 15mg, Qd, for 7 days. | Drug | Tolvaptan 15mg tablet |
Primary outcome
Serum concentration of tolvaptan and its metabolites DM-4103 and DM-4107
Time frame: blood sample will be collected at predose, 2,4,6,8,12,24 hour of first drug administration and predose of sixth drug administration and predose,2,4,6,8,12,24 hour of seventh drug administration
2 secondary outcomes
pharmacological parameter:Serum concentration of sodium and potassium
Time frame: Blood sample will be collected at predose on day1;12,24hour of first dosing;before breakfast on day3 to day6;predose and 12,24hour of seventh dosing
pharmacological parameter:24-hr urine
Time frame: From day-1 to day 8
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 24 May 2011.
- Derived from this study: PubMed 38344178Liu H, Wang Y, Liu T, Chen Y, Zheng X, Liu M, Zhao Q, Zeng M, Jiang J, Mao Y, Hu P. Pharmacokinetics, pharmacodynamics and safety of 15 mg-tolvaptan administered orally for 7 consecutive days to Chinese patients with child-Pugh B cirrhosis. Front Pharmacol. 2024 Jan 26;15:1324299. doi: 10.3389/fphar.2024.1324299. eCollection 2024.
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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 1 study testing tolvaptan in people with Hepatic Cirrhosis and Ascites, 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 4 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 24 May 2011. 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 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.
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?
Serum concentration of tolvaptan and its metabolites DM-4103 and DM-4107 (time frame: blood sample will be collected at predose, 2,4,6,8,12,24 hour of first drug administration and predose of sixth drug administration and predose,2,4,6,8,12,24 hour of seventh drug administration). 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 NCT01359462, 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 24 May 2011.