Trial Outcomes & Findings for SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study (NCT NCT00590564)

NCT ID: NCT00590564

Last Updated: 2016-01-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2016-01-15

Participant Flow

Participant milestones

Measure	All Patients 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 Study STARTED	42
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	All Patients 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 Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	6
Overall Study Protocol Violation	1
Overall Study Patient Found to be Ineligible	1
Overall Study Patient Non-compliance	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Patients n=42 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

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

Outcome measures

Measure	All Patients n=24 Participants 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.
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. Responders	5 participants
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. Non-responders	19 participants

Adverse Events

All Patients

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients n=24 participants at risk 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.
Cardiac disorders Conduction abnormality	4.2% 1/24 • Number of events 1
Skin and subcutaneous tissue disorders Cellulitis (skin)	4.2% 1/24 • Number of events 1
Reproductive system and breast disorders Pneumonia	4.2% 1/24 • Number of events 1

Other adverse events

Measure	All Patients n=24 participants at risk 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.
Gastrointestinal disorders Abdominal pain/cramping	8.3% 2/24 • Number of events 2
Hepatobiliary disorders Bilirubin	8.3% 2/24 • Number of events 2
Metabolism and nutrition disorders Hyperglycemia	16.7% 4/24 • Number of events 4
Metabolism and nutrition disorders Hypoalbuminemia	8.3% 2/24 • Number of events 2
Blood and lymphatic system disorders Neutrophils	12.5% 3/24 • Number of events 3
Blood and lymphatic system disorders Aspartate Aminotransferase (AST)	25.0% 6/24 • Number of events 6
Blood and lymphatic system disorders Alanine Aminotransferase (ALT)	45.8% 11/24 • Number of events 11

Additional Information

Dr. Gary Deng

Memorial Sloan Kettering Cancer Center

Phone: 646-888-0841

Email: dengg@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place