Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

January 12, 2016

Primary Completion Date

July 15, 2020

Study Completion Date

July 15, 2020

Conditions
Chronic Hepatitis C Virus Infection
Interventions
DRUG

P1101 + Ribavirin

P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily

DRUG

PEG-Intron + Ribavirin

PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily

Trial Locations (39)

Unknown

Beijing Ditan Hospital Capital Medical University, Beijing

Gansu Wuwei Tumour Hospital, Gansu

The First Hospital of Lanzhou University, Gansu

The Fourth Affiliated Hospital of Harbin Medical University, Harbin

Henan Provincial People's Hospital, Henan

Luoyang Central Hospital, Henan

The First Hospital of Jilin University, Jilin

Peace Hospital Affiliated to Changzhi Medical College, Shanxi

The Sixth People's Hospital of Shenyang, Shenyang

Tangdu Hospital, Fourth Military Medical University, Xi'an

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an

Xijing Hospital, Fourth Military Medical University, Xi'an

Soonchunhyang University Seoul Hospital, Asan

Pusan National University Hospital, Busan

Kyungpook National University Hospital, Daegu

Inha University Medical Center, Incheon

Hanyang University Seoul Hospital, Seoul

Seoul Metropolitan Government - Seoul National University Boramae Medical Center, Seoul

Yonsei University Gangnam Severance Hospital, Seoul

Saint Vincent Catholic Hospital, Suwon

Changhua Christian Hospital, Changhua

Chang Gung Memorial Hospital, Chiayi Branch, Chiayi City

Chia-Yi Christian Hospital, Chiayi City

Dalin Tzu Chi Hospital, Chiayi City

St. Martin De Porres Hospital, Chiayi City

Hualien Tzu Chi Hospital, Hualien City

Chang Gung Memorial Hospital, Kaohsiung Branch, Kaohsiung City

E-Da Hospital, Kaohsiung City

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

Chang Gung Memorial Hospital, Keelung Branch, Keelung

Chang Gung Memorial Hospital, Linkou, New Taipei City

China Medical University Hospital, Taichung

Taichung Veterans General Hospital, Taichung

Chi Mei Hospital, Liouying, Tainan City

Chi Mei Medical Center, Tainan City

National Cheng Kung University Hospital, Tainan City

National Taiwan University Hospital, Taipei

Taitung MacKay Memorial Hospital, Taitung

National Taiwan University Hospital Yun-Lin Branch, Yuanlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaEssentia

INDUSTRY

NCT04382937 - Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection | Biotech Hunter | Biotech Hunter