Chronic Hepatitis C Virus InfectionPhase 3NCT04382937
Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
A Phase 3 study testing P1101 + Ribavirin and PEG-Intron + Ribavirin in people with Chronic Hepatitis C Virus Infection, run by PharmaEssentia at 39 sites in 3 countries.
Trial summary
Primary objective: To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Virus Infection
- What is being tested?
- P1101 + Ribavirin and PEG-Intron + Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 39 sitesin 3 countries
- Study dates
- 12 Jan 2016to 15 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age (or other age required by local regulations); subjects who are over 70 years of age must be in generally good health.
- Confirmed diagnosis of chronic hepatitis with HCV genotype 2 infection. Chronicity is defined as having proven clinical evidence of chronic hepatitis, e.g. a duration of disease longer than 24 weeks before dosing, OR positive for anti-HCV antibody and HCV RNA at screening with biopsy-proven chronic hepatitis C, OR fibrosis.
- Compensated liver disease defined by normal or elevated ALT ≤10 x ULN, total bilirubin level <2 mg/dL (except in Gilbert's syndrome), normal albumin, normal INR (INR ≤1.5)
- Interferon treatment naïve: never received any interferon.
- No other known form of chronic liver disease apart from chronic hepatitis C infection. But mild and moderate fatty liver diseases can be included.
- Hemoglobin ≥12 g/dL in men or ≥11 g/dL in women, WBC count ≥3,000/mm3, ANC ≥1,500/mm3, platelet count ≥90,000/mm3; and estimated glomerular filtration rate >60 mL/min.
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- Female and male subjects, and their partners of reproductive potential using effective means of contraception during the whole trial period.
- Be able to attend all scheduled visits and to comply with all study procedures;
- Be able to provide written informed consent.
Who cannot join
- Any of the following is cause for exclusion from the study:
- Decompensated liver disease, including overt clinical symptom and sign of complications related to portal hypertension.
- Clinically significant illness or surgery within 4 weeks prior to dosing.
- Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
- Positive test for hepatitis B surface antigen or human immunodeficiency virus at screening.
- Clinically significant abnormal vital signs at screening.
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- Evidence of severe retinopathy by fundoscopy except age-related macular degeneration at screening.
- Significant alcohol or illicit drug abuse within one year prior to the screening visit or refusal to abstain from excessive alcohol consumption as defined above or illicit drugs throughout the study.
- Pregnant or breast feeding female subjects.
- Therapy with any systemic anti-viral, anti-neoplastic, and immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 4 weeks prior to the first dose of study drug.
- Use of an investigational drug or participation in an investigational drug trial within 4 weeks from the first dose.
- Known clinically significant presence of any gastrointestinal pathology, clinically significant unresolved gastrointestinal symptoms, clinically significant liver (other than CHC) or clinically significant kidney disease (including but not limited to those with chronic renal failure on dialysis), or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Hospital Anxiety and Depression Scale (HADS) score >10 on depression scale at screening that indicates clinically significant presence of depression determined by investigators.
- Clinically significant presence of severe neurological disorders, e.g. uncontrolled seizure disorders.
- Clinically significant presence of severe cardiovascular conditions and severe pulmonary conditions (including but not limited to pulmonary infiltrates, pneumonia, pneumonitis, chronic obstructive lung disease), uncontrolled immunologic, uncontrolled autoimmune, uncontrolled endocrine, uncontrolled metabolic, haematological, severe coagulation disorders or severe blood dyscrasias or other severe uncontrolled systemic disease.
- A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraception or hyaluronic acid injections in joints for osteoarthritis;
- Body organ transplant and are taking immunosuppressants;
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured, and carcinoma in situ of cervix); However, subjects who are cancer survivors not on maintenance therapy and who had no malignant diseases history within the past 5 years could be recruited.
- History of or ongoing opportunistic infection.
- Serious local infection or systemic infection within the 3 months prior to screening.
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
Taiwan19 sites
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
Chi Mei Medical Center
Tainan
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taitung MacKay Memorial Hospital
Taitung
National Taiwan University Hospital Yun-Lin Branch
Yuanlin
China12 sites
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 City
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
South Korea8 sites
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
About this study
Official title: An Open-label, Randomized, Active Control Study to Demonstrate Non-Inferiority in Efficacy, and to Compare Safety and Tolerability of P1101 + Ribavirin to PEG-Intron + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic HCV Genotype 2 Infection
Primary objective:
To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection
Read the detailed description
Secondary objective:
To determine and compare the efficacy, safety, tolerability and immunogenicity of PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily
- Conditions
- Chronic Hepatitis C Virus Infection
- Being tested
- P1101 + Ribavirin, PEG-Intron + Ribavirin
- Keywords
- P1101, HCV, PEG-Intron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1101 + RibavirinDrug
Also called Ropeginterferon alfa-2b
P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily
PEG-Intron + RibavirinDrug
Also called Peginterferon alfa-2b
PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily
| Study group | Role | What they receive |
|---|---|---|
| P1101 + Ribavirin | Experimental | P1101 400 µg SC Q2W Receives: Drug: P1101 + Ribavirin |
| PEG-Intron + Ribavirin | Active comparator | PEG-Intron 1.5 µg per kg SC Q1W Receives: Drug: PEG-Intron + Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects with undetectable serum HCV RNA at follow up week 12
Percentage of subjects with SVR12 (undetectable serum HCV RNA, i.e. <12 IU/mL, at follow up week 12) in each treatment group
Measured: Follow Week 12
Secondary outcomes (5)
Subjects with undetectable serum HCV RNA
Percentage of subjects with undetectable serum HCV RNA at treatment week 4, 8, 12, 24 (end of treatment) and follow up week 24 in each treatment group
Measured: Treatment Week 4, 8, 12, 24 and Follow Week 24
Number of subjects with adverse events
Number of subjects with adverse events in each treatment group
Measured: Through study Follow Week 24
Number of subjects with clinically significant laboratory abnormalities
Number of subjects with clinically significant laboratory abnormalities in each treatment group
Measured: Through study Follow Week 24
Subjects with anti-drug antibodies
Percentage of subjects with positive anti-drug antibodies (the anti-peginterferon and the anti-Peg) at follow up week 12 and 24
Measured: Follow Week 12 and 24
Subjects with neutralizing antibody
Percentage of subjects with positive neutralizing antibody at follow up week 12 and 24
Measured: Follow Week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start12 Jan 2016
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEssentia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi-Wen Huang, MD/PhD, Study director, PharmaEssentia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382937
- Sponsor's protocol ID
- A14-301
- Status last verified
- Jan 2022
- First submitted
- 28 Apr 2020
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Active Control Study to Demonstrate Non-Inferiority in Efficacy, and to Compare Safety and Tolerability of P1101 + Ribavirin to PEG-Intron + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic HCV Genotype 2 Infection
- ClinicalTrials.gov ID
- NCT04382937
- Acronym / sponsor ID
- A14-301
- Conditions
- Chronic Hepatitis C Virus Infection
- Keywords
- P1101, HCV, PEG-Intron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- PharmaEssentiaIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection
Detailed description
Secondary objective:
To determine and compare the efficacy, safety, tolerability and immunogenicity of PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P1101 + Ribavirin | Experimental | Drug: P1101 + RibavirinP1101 400 µg SC Q2W |
| PEG-Intron + Ribavirin | Active comparator | Drug: PEG-Intron + RibavirinPEG-Intron 1.5 µg per kg SC Q1W |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults ≥18 years of age (or other age required by local regulations); subjects who are over 70 years of age must be in generally good health.
- Confirmed diagnosis of chronic hepatitis with HCV genotype 2 infection. Chronicity is defined as having proven clinical evidence of chronic hepatitis, e.g. a duration of disease longer than 24 weeks before dosing, OR positive for anti-HCV antibody and HCV RNA at screening with biopsy-proven chronic hepatitis C, OR fibrosis.
- Compensated liver disease defined by normal or elevated ALT ≤10 x ULN, total bilirubin level <2 mg/dL (except in Gilbert's syndrome), normal albumin, normal INR (INR ≤1.5)
- Interferon treatment naïve: never received any interferon.
- No other known form of chronic liver disease apart from chronic hepatitis C infection. But mild and moderate fatty liver diseases can be included.
Key exclusion criteria (20 listed)
- Decompensated liver disease, including overt clinical symptom and sign of complications related to portal hypertension.
- Clinically significant illness or surgery within 4 weeks prior to dosing.
- Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
- Positive test for hepatitis B surface antigen or human immunodeficiency virus at screening.
- Clinically significant abnormal vital signs at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P1101 + RibavirinAlso: Ropeginterferon alfa-2bP1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily | Drug | P1101 + Ribavirin |
| PEG-Intron + RibavirinAlso: Peginterferon alfa-2bPEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily | Drug | PEG-Intron + Ribavirin |
Primary outcome
Subjects with undetectable serum HCV RNA at follow up week 12
Time frame: Follow Week 12
Percentage of subjects with SVR12 (undetectable serum HCV RNA, i.e. <12 IU/mL, at follow up week 12) in each treatment group
5 secondary outcomes
Subjects with undetectable serum HCV RNA
Time frame: Treatment Week 4, 8, 12, 24 and Follow Week 24
Number of subjects with adverse events
Time frame: Through study Follow Week 24
Number of subjects with clinically significant laboratory abnormalities
Time frame: Through study Follow Week 24
Subjects with anti-drug antibodies
Time frame: Follow Week 12 and 24
Subjects with neutralizing antibody
Time frame: Follow Week 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Wen Huang, MD/PhD study director
PharmaEssentia
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P1101 + Ribavirin and PEG-Intron + Ribavirin in people with Chronic Hepatitis C Virus Infection, run by PharmaEssentia at 39 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Taiwan, China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects with undetectable serum HCV RNA at follow up week 12 (time frame: Follow Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.