Trial Outcomes & Findings for Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671) (NCT NCT00728494)

NCT ID: NCT00728494

Last Updated: 2015-07-28

Results Overview

Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program

• Recruitment status: COMPLETED
• Target enrollment: 99 participants
• Primary outcome timeframe: At the end of the 48-week treatment period
• Results posted on: 2015-07-28

Participant Flow

Participant milestones

Measure	Treatment and Patient Assistance Program Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone PegIntron/Rebetol treatment only
Overall Study STARTED	60	39
Overall Study COMPLETED	51	32
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Measure	Treatment and Patient Assistance Program Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone PegIntron/Rebetol treatment only
Overall Study Adverse Event	7	0
Overall Study Withdrawal by Subject	0	2
Overall Study Lack of Efficacy	2	4
Overall Study No data available	0	1

Baseline Characteristics

Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

Baseline characteristics by cohort

Measure	Treatment and Patient Assistance Program n=60 Participants Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone n=39 Participants PegIntron/Rebetol treatment only	Total n=99 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 12 • n=5 Participants	42 years STANDARD_DEVIATION 14 • n=7 Participants	45 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	21 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment Poland	60 participants n=5 Participants	39 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of the 48-week treatment period

Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program

Outcome measures

Measure	Treatment and Patient Assistance Program n=60 Participants Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone n=39 Participants PegIntron/Rebetol treatment only
The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C	51 Participants	32 Participants

PRIMARY outcome

Timeframe: Measured at 6 months post-treatment

Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment

Outcome measures

Measure	Treatment and Patient Assistance Program n=51 Participants Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone n=12 Participants PegIntron/Rebetol treatment only
The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment	29 Participants	7 Participants

PRIMARY outcome

Timeframe: Measured at end of treatment and 6 months post-treatment

Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment

Outcome measures

Measure	Treatment and Patient Assistance Program n=51 Participants Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone n=12 Participants PegIntron/Rebetol treatment only
The Number of Participants Who Relapsed at 6 Months Post-treatment	17 Participants	4 Participants

SECONDARY outcome

Timeframe: Maximum 48-week treatment duration

Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.

Outcome measures

Measure	Treatment and Patient Assistance Program n=60 Participants Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone n=39 Participants PegIntron/Rebetol treatment only
Average Length of Treatment 2-12 weeks	6 Participants	5 Participants
Average Length of Treatment 13-47 weeks	3 Participants	2 Participants
Average Length of Treatment 48 weeks and one of the drugs at a dose <80%	13 Participants	9 Participants
Average Length of Treatment 48 weeks and both drugs at a dose >=80%	38 Participants	23 Participants

SECONDARY outcome

Timeframe: Up to 48-week treatment duration

Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week

Outcome measures

Measure	Treatment and Patient Assistance Program n=60 Participants Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone n=39 Participants PegIntron/Rebetol treatment only
Average Dosage of PegIntron	1.46 micrograms/kg/week Standard Deviation 0.16	1.45 micrograms/kg/week Standard Deviation 0.25

SECONDARY outcome

Timeframe: Up to 48-week treatment duration

Rebetol dosage was expressed in milligrams per kilogram of body weight per day.

Outcome measures

Measure	Treatment and Patient Assistance Program n=60 Participants Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.	Treatment Alone n=39 Participants PegIntron/Rebetol treatment only
Average Dosage of Rebetol	12.63 mg/kg/day Standard Deviation 1.72	12.01 mg/kg/day Standard Deviation 2.86

Adverse Events

Treatment and Patient Assistance Program

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Treatment Alone

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment and Patient Assistance Program n=60 participants at risk	Treatment Alone n=39 participants at risk
Blood and lymphatic system disorders ANAEMIA	20.0% 12/60 • Number of events 15	25.6% 10/39 • Number of events 10
Blood and lymphatic system disorders GRANULOCYTOPENIA	0.00% 0/60	12.8% 5/39 • Number of events 5
Blood and lymphatic system disorders NEUTROPENIA	3.3% 2/60 • Number of events 2	5.1% 2/39 • Number of events 2
Blood and lymphatic system disorders THROMBOCYTOPENIA	10.0% 6/60 • Number of events 6	0.00% 0/39
Ear and labyrinth disorders VERTIGO	0.00% 0/60	5.1% 2/39 • Number of events 2
Gastrointestinal disorders ABDOMINAL PAIN	1.7% 1/60 • Number of events 1	7.7% 3/39 • Number of events 3
Gastrointestinal disorders VOMITING	0.00% 0/60	5.1% 2/39 • Number of events 2
General disorders ASTHENIA	6.7% 4/60 • Number of events 4	7.7% 3/39 • Number of events 3
General disorders CHEST PAIN	1.7% 1/60 • Number of events 1	7.7% 3/39 • Number of events 3
General disorders FATIGUE	6.7% 4/60 • Number of events 4	7.7% 3/39 • Number of events 3
General disorders INFLUENZA LIKE ILLNESS	10.0% 6/60 • Number of events 6	2.6% 1/39 • Number of events 1
General disorders PYREXIA	1.7% 1/60 • Number of events 1	20.5% 8/39 • Number of events 11
Infections and infestations PNEUMONIA	0.00% 0/60	5.1% 2/39 • Number of events 2
Investigations NEUTROPHIL COUNT DECREASED	6.7% 4/60 • Number of events 5	0.00% 0/39
Investigations WEIGHT DECREASED	21.7% 13/60 • Number of events 14	17.9% 7/39 • Number of events 8
Metabolism and nutrition disorders APPETITE DISORDER	0.00% 0/60	7.7% 3/39 • Number of events 3
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/60	5.1% 2/39 • Number of events 2
Nervous system disorders HEADACHE	1.7% 1/60 • Number of events 1	5.1% 2/39 • Number of events 2
Psychiatric disorders DEPRESSION	8.3% 5/60 • Number of events 5	0.00% 0/39
Psychiatric disorders DYSTHYMIC DISORDER	0.00% 0/60	5.1% 2/39 • Number of events 3
Psychiatric disorders INSOMNIA	5.0% 3/60 • Number of events 3	5.1% 2/39 • Number of events 2
Respiratory, thoracic and mediastinal disorders COUGH	1.7% 1/60 • Number of events 1	7.7% 3/39 • Number of events 5
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/60	7.7% 3/39 • Number of events 3

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee All the information obtained in the course of conducting the study, including all data concerning the study and its results, are confidential and cannot be disclosed to any third parties without the consent of Schering-Plough.
• Publication restrictions are in place

Restriction type: OTHER