Trial Outcomes & Findings for Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population (NCT NCT02601976)

NCT ID: NCT02601976

Last Updated: 2018-09-27

Results Overview

To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 64 participants
• Primary outcome timeframe: Post treatment Week 24
• Results posted on: 2018-09-27

Participant Flow

Participant milestones

Measure	PegInterferon Alfa-2a and Ribavirin PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Overall Study STARTED	64
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population

Baseline characteristics by cohort

Measure	PegInterferon Alfa-2a and Ribavirin n=64 Participants PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Age, Customized Count	35.4 participants STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Count · Female	28 Participants n=5 Participants
Sex: Female, Male Count · Male	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	64 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Pakistan	64 Participants n=5 Participants
Number of HCV Patients confirmed through Polymerase Chain Reaction	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Post treatment Week 24

Population: Among those who achieved ETR (i.e. 56 participants) were eligible for SVR analysis after 24 weeks of post treatment.

To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR

Outcome measures

Measure

PegInterferon Alfa-2a and Ribavirin n=56 Participants PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Number of Participants With Sustained Virological Response (SVR)

49 Participants

PRIMARY outcome

Timeframe: Upto 48 weeks

To determine the End Treatment Response (ETR) rate of all patients treated with PegInterferon alfa-2a plus Ribavirin

Outcome measures

Measure

PegInterferon Alfa-2a and Ribavirin n=64 Participants PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Number of Participants With End Treatment Response

56 Participants

SECONDARY outcome

Timeframe: Upto 48 weeks

To determine the number of patients treated with PegInterferon Alfa-2a plus Ribavirin who experience any adverse drug reaction. All ADR are reported as per patient information leaflet

Outcome measures

Measure

PegInterferon Alfa-2a and Ribavirin n=64 Participants PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Number of Participants Who Reported Adverse Events

10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

To evaluate the Rapid Virological Response (RVR) of all patients treated with PegInterferon Alfa-2a plus Ribavirin at 4 weeks of treatment

Outcome measures

Measure

PegInterferon Alfa-2a and Ribavirin n=64 Participants PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Number of Participants With Rapid Virological Response (RVR)

48 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Upto 48 weeks

To determine and compare the changes in quality of life (QOL) from baseline to end of the treatment. Health-Related Quality of Life (HRQOL) Questionnaire (SF-36) was used to measure the quality of life. The SF-36 is a widely used questionnaire, and consists of 36 questions measuring eight concepts: Physical Function (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Function (SF), Role Emotional (RE), and Mental Health (MH). The scoring of the SF-36 questionnaire in our study was conducted upon a 0-100 scale, with higher scores reflecting better health status.

Outcome measures

Measure	PegInterferon Alfa-2a and Ribavirin n=64 Participants PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Mean of Physical Component Score & Mental Component Score to Determine Quality of Life Physical Component Score	50.62 score on a scale Standard Deviation 8.22
Mean of Physical Component Score & Mental Component Score to Determine Quality of Life Mental Component Score	54.89 score on a scale Standard Deviation 9.61

Adverse Events

PegInterferon Alfa-2a and Ribavirin

Serious events: 0 serious events

Other events: 10 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PegInterferon Alfa-2a and Ribavirin n=64 participants at risk PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight Peginterferon alfa-2a: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients. Ribavirin: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
General disorders Body Pain	7.8% 5/64
Immune system disorders Rashes	3.1% 2/64
Gastrointestinal disorders Epigastric Pain	3.1% 2/64
General disorders Flu	1.6% 1/64

Additional Information

Mr. Jaffer Bin Baqar

Getz Pharma

Phone: 111111511

Email: jaffer.baqar@getzpharma.com

Results disclosure agreements

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