Trial Outcomes & Findings for Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients (NCT NCT00871845)

Results Overview

Early virological response (EVR) defined as a greater than 2-log10 decline in serum HCV RNA from the pretreatment baseline or an undetectable serum HCV RNA at treatment week 12

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Week 12

Results posted on

2018-11-05

Participant Flow

While the initial study design included a drug intervention, drug intervention was not done. The study team could not identify an adequate study population willing to undergo drug intervention and funding to cover the costs of the drug intervention. Therefore, the only intervention was weight loss instruction/management.

Participant milestones

Participant milestones
Measure	Lean Treatment naive HCV Genotype 1 infected patients with BMI\<25	Overweight Treatment naive HCV Genotype 1 infected patients with BMI \>=25
Overall Study STARTED	11	25
Overall Study COMPLETED	11	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lean n=11 Participants Lean (BMI\<25)	Overweight n=25 Participants Overweight (BMI\>=25)	Total n=36 Participants Total of all reporting groups
Age, Customized Age > 50 years	4 Participants n=99 Participants	20 Participants n=107 Participants	24 Participants n=206 Participants
Age, Customized Age ≤ 50 years	7 Participants n=99 Participants	5 Participants n=107 Participants	12 Participants n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	14 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	11 Participants n=107 Participants	15 Participants n=206 Participants

PRIMARY outcome

Timeframe: Week 12

Early virological response (EVR) defined as a greater than 2-log10 decline in serum HCV RNA from the pretreatment baseline or an undetectable serum HCV RNA at treatment week 12

Outcome measures

Outcome measures
Measure	Lean n=11 Participants Lean (BMI\<25)	Overweight n=25 Participants Overweight (BMI\>=25)
Percentage of Participants With HCV RNA (Early Virological Response)	82 percentage of participants	52 percentage of participants

PRIMARY outcome

Timeframe: Weight loss as of Week 12

Mean weight change from week 0 to week 12

Outcome measures

Outcome measures
Measure	Lean n=11 Participants Lean (BMI\<25)	Overweight n=25 Participants Overweight (BMI\>=25)
Body Weight Loss	1.44 kg Standard Deviation 3.82	3.44 kg Standard Deviation 4.12

PRIMARY outcome

Timeframe: Week 12

EVR compared between overweight subjects who achieved significant weight loss (\>=3%) and those who did not

Outcome measures

Outcome measures
Measure	Lean n=15 Participants Lean (BMI\<25)	Overweight n=10 Participants Overweight (BMI\>=25)
Percentage of Participants With Early Virological Response (EVR) and Significant Weight Loss	69 percentage of participants	33 percentage of participants

Adverse Events

Lean

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overweight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hossam Kandil

Allegheny Singer Research Institute

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place