Trial Outcomes & Findings for S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C (NCT NCT00475176)

Last Updated: 2013-07-05

Results Overview

Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Days 7 to 14 of therapy

Results posted on

2013-07-05

Participant Flow

Twenty-four patients were enrolled at National Institutes of Health Clinic Center between October 2007 and April 2009.

Participant milestones

Participant milestones
Measure	Hepatitis C Treated With Peginterferon and Ribavirin Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks.
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Hepatitis C Treated With Peginterferon and Ribavirin Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hepatitis C Treated With Peginterferon and Ribavirin n=24 Participants Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
Age Continuous	52.5 year n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants
Race/Ethnicity, Customized White	21 participants n=5 Participants
Body Mass Index	27.2 kg/m^2 STANDARD_DEVIATION 3.74 • n=5 Participants
Ishak Fibrosis	2 Units on a scale n=5 Participants
Cirrhosis Cirrhosis	5 participants n=5 Participants
Cirrhosis Non-Cirrhosis	19 participants n=5 Participants
Previous Therapy Interferon/ribavirin	3 participants n=5 Participants
Previous Therapy Peginterferon/ribavirin	21 participants n=5 Participants
Baseline HCV RNA Level	6.3 log10 (IU/mL) STANDARD_DEVIATION 0.6 • n=5 Participants

PRIMARY outcome

Timeframe: Days 7 to 14 of therapy

Population: Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.

Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy

Outcome measures

Outcome measures
Measure	Hepatitis C Treated With Peginterferon and Ribavirin n=20 Participants Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
Improvement in Viral Kinetics During the First 2 Weeks of Therapy	14 participants

SECONDARY outcome

Timeframe: 12 weeks from start of therapy

2-log decline in HCV RNA by week 12 (early virological response) and sustained eradication of HCV RNA (sustained virological response).

Outcome measures

Outcome measures
Measure	Hepatitis C Treated With Peginterferon and Ribavirin n=20 Participants Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
2-log Decline in HCV RNA by Week 12 (Early Virological Response) and Sustained Eradication of HCV RNA (Sustained Virological Response).	11 participants

Adverse Events

Hepatitis C Treated With Peginterferon and Ribavirin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hepatitis C Treated With Peginterferon and Ribavirin n=24 participants at risk Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
Skin and subcutaneous tissue disorders Rash attributed to ribavirin	4.2% 1/24 • Number of events 1
General disorders Benzodiazepine abuse	4.2% 1/24 • Number of events 1

Additional Information

Jay H. Hoofnagle, M.D.

National Institute of Diabetes and Digestive and Kidney Diseases, National In

Phone: 301-496-1333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place