- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048788
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
March 13, 2016 updated by: Otsuka Pharmaceutical Co., Ltd.
A Multicenter, Uncontrolled, Open-label Phase 3 Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy.
Based on the change in body weight, on Day 7 it will be decided whether to continue administration at the same dose or to increase the dose, and then OPC-41061 will be orally administered for an additional 7 days at either 7.5 mg/day or, if diuretic effect for the initial 7-day administration is insufficient, at an increased dose of 15 mg/day.
Plasma drug level, efficacy, and safety of OPC-41061 by 14-day repeated administration will be investigated.
Study Overview
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chubu Region, Japan
-
Chugoku Region, Japan
-
Kanto Region, Japan
-
Kinki Region, Japan
-
Kyushu Region, Japan
-
Tohoku Region, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients judged as having cirrhosis* based on previous imaging diagnosis
- Definition of cirrhosis includes patients with collateral circulation due to chronic hepatic impairment
- Patients with ascites in whom the dose of existing diuretics cannot be increased due to risk of adverse drug reactions such as electrolyte abnormalities, or in whom sufficient therapeutic effect cannot be obtained with existing diuretics
- Patients who have been receiving oral combination therapy with a loop diuretic and an anti-aldosterone agent from at least 7 days prior to receipt of informed consent, with a dose combination of either loop diuretic equivalent to furosemide 40 mg/day or higher plus spironolactone 25 mg/day or higher, or loop diuretic equivalent to furosemide 20 mg/day or higher plus spironolactone 50 mg/day or higher
- Patients who are hospitalized or who can be hospitalized for the trial
- Patients capable of giving informed consent
- Patients who, together with their partner, agree to use an appropriate method of contraception until 4 weeks after the final trial drug administration
Exclusion Criteria:
- Patients with any of the following complications or symptoms:
- Hepatic encephalopathy (hepatic coma of grade 2 or higher)
- Hepatocellular carcinoma with imaging-diagnosed vascular infiltration into trunk or primary branch of portal vein, inferior vena cava, or trunk of hepatic vein
- Endoscopic findings from screening examination or from within 30 days prior to screening examination indicating the need for new therapy for esophageal or gastric varices during the trial period
- Repeated hemorrhoidal bleeding due to rectal varicose veins within 30 days prior to informed consent
- Heart failure (New York Heart Association Class III or IV)
- Anuria
- Impaired urination due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- Patients with a history of any of the following disorders:
- Cerebrovascular disorder within 30 days prior to informed consent
- Hypersensitivity or idiosyncratic reaction to benzazepine derivatives (such as mozavaptan hydrochloride or benazepril hydrochloride)
- Morbidly obese patients with a body mass index (BMI: body weight (kg)/height (m)2) exceeding 35
- Patients with sitting systolic blood pressure lower than 90 mmHg
- Patients with any of following abnormal clinical laboratory values at time of the screening examination: Hemoglobin lower than 8.0 g/dL, total bilirubin higher than 4.0 mg/dL, serum creatinine higher than 2.0 mg/dL, serum sodium higher than 147 mEq/L, or serum potassium higher than 5.5 mEq/L
- Patients who are unable to take oral medication
- Female patients who are pregnant, possibly pregnant, or breast-feeding, or who are planning to become pregnant
- Patients who have used albumin preparations (therapeutic agents for hypoalbuminemia) or blood products containing albumin from within 7 days prior to informed consent
- Patients who received any investigational drug other than OPC-41061 within 30 days prior to informed consent
- Patients who have previously received OPC-41061
- Any patient who, in the opinion of the principle investigator or subinvestigator, is inappropriate for participation in the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: OPC
|
OPC-41061 tablets will be orally administered once daily after breakfast at 7.5 mg on Day 1 to 7 and at either 7.5 or 15 mg on Day 8 to 14.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight
Time Frame: Baseline, Day 14 or end of administration
|
Changes in body weight from baseline at the end of administration
|
Baseline, Day 14 or end of administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
January 7, 2010
First Submitted That Met QC Criteria
January 12, 2010
First Posted (ESTIMATE)
January 14, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
April 11, 2016
Last Update Submitted That Met QC Criteria
March 13, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 156-08-002
- JapicCTI-100983 (REGISTRY: JAPIC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cirrhosis
-
Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
-
University Health Network, TorontoUnknown
-
National Institute of Diabetes and Digestive and...National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingPrimary Biliary CirrhosisChina
-
Northwestern UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
RenJi HospitalNot yet recruiting
-
Nanfang Hospital, Southern Medical UniversityRecruiting
-
Institute of Liver and Biliary Sciences, IndiaRecruiting
-
SUUMC Central Military Hospital Dr Carol DavilaRecruiting
-
The Cleveland ClinicRecruiting
Clinical Trials on OPC-41061
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Otsuka Pharmaceutical Development & Commercialization...Otsuka Pharmaceutical Co., Ltd.CompletedPolycystic Kidney Disease, Autosomal DominantUnited States, Belgium, United Kingdom, Russian Federation, France, Australia, Netherlands, Italy, Japan, Denmark, Romania, Poland, Canada, Argentina, Germany
-
Otsuka Pharmaceutical Development & Commercialization...TerminatedHyponatremia | Inappropriate ADH Syndrome | Dilutional HyponatremiaUnited States
-
Otsuka Pharmaceutical Development & Commercialization...CompletedAutosomal Dominant Polycystic Kidney DiseaseNetherlands
-
Otsuka Pharmaceutical Co., Ltd.CompletedAutosomal Dominant Polycystic Kidney DiseaseJapan
-
Otsuka Pharmaceutical Co., Ltd.CompletedChronic Renal FailureJapan
-
Otsuka Pharmaceutical Development & Commercialization...RecruitingAutosomal Recessive Polycystic Kidney Disease (ARPKD)United States, Belgium, Spain, Germany, United Kingdom, Poland
-
Otsuka Pharmaceutical Co., Ltd.CompletedAutosomal Dominant Polycystic Kidney DiseaseJapan
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Otsuka Pharmaceutical Co., Ltd.Completed