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SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00590564
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Intervention Drug: Sho-saiko-to
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
Period Title: Overall Study
Started 42
Completed 24
Not Completed 18
Reason Not Completed
Withdrawal by Subject             4
Lost to Follow-up             6
Protocol Violation             1
Patient Found to be Ineligible             1
Patient Non-compliance             6
Arm/Group Title All Patients
Hide Arm/Group Description Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
  95.2%
>=65 years
2
   4.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
13
  31.0%
Male
29
  69.0%
1.Primary Outcome
Title To Determine the Effects of Sho-saiko-to on Hepatic Injury in Patients With Chronic Hepatitis C Who Are Intolerant or Have a Specific Contraindication to Interferon-based Therapy.
Hide Description Response is determined by improvement of 2 points or greater as per Knodell's histology activity index (HAI) scores in paired comparisons of pre and post liver biopsy
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
Responders 5
Non-responders 19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   3/24 (12.50%)    
Cardiac disorders   
Conduction abnormality  1  1/24 (4.17%)  1
Reproductive system and breast disorders   
Pneumonia  1  1/24 (4.17%)  1
Skin and subcutaneous tissue disorders   
Cellulitis (skin)  1  1/24 (4.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-2.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   14/24 (58.33%)    
Blood and lymphatic system disorders   
Neutrophils  1  3/24 (12.50%)  3
Aspartate Aminotransferase (AST)  1  6/24 (25.00%)  6
Alanine Aminotransferase (ALT)  1  11/24 (45.83%)  11
Gastrointestinal disorders   
Abdominal pain/cramping  1  2/24 (8.33%)  2
Hepatobiliary disorders   
Bilirubin  1  2/24 (8.33%)  2
Metabolism and nutrition disorders   
Hyperglycemia  1  4/24 (16.67%)  4
Hypoalbuminemia  1  2/24 (8.33%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-2.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gary Deng
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-0841
EMail: dengg@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00590564    
Other Study ID Numbers: 02-073
First Submitted: December 21, 2007
First Posted: January 10, 2008
Results First Submitted: December 14, 2015
Results First Posted: January 15, 2016
Last Update Posted: January 15, 2016