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Hepatitis C, ChronicPhase 2NCT01587586

Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection

A Phase 2 study testing PEGASYS 180 µg Q1W, P1101 180 µg Q1W, 48 doses and P1101 270µg Q1W, 48 doses in people with Hepatitis C, Chronic, run by PharmaEssentia at 13 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary objectives: The purpose of this study is to determine and compare the sustained virologic response (SVR, undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups. To determine and compare the safety and tolerability of P1101 + Ribavirin across treatment groups. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
PEGASYS 180 µg Q1W, P1101 180 µg Q1W, 48 doses and P1101 270µg Q1W, 48 doses
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
13 sitesTaiwan
Study dates
18 Oct 2011to 22 Nov 2016
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults ≥18 years of age (≥ 20 years for subjects enrolled in Taiwan); subjects who are over 70 years of age must be in generally good health.
  • Confirmed diagnosis of chronic hepatitis C (CHC) virus genotype 1 infection: (1) Positive for anti-HCV antibody or HCV RNA at least 6 months before screening, and positive for HCV RNA genotype 1 or anti-HCV antibody at the time of screening; or (2) Positive for anti-HCV antibody or HCV RNA genotype 1 at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis).
  • Compensated liver disease: with normal or elevated alanine aminotransaminase (ALT)/ aspartate aminotransferase (AST) (≤ 5 times the upper limit of normal), normal bilirubin level (< 2 mg/dL, except for Gilbert's syndrome), normal albumin, normal prothrombin time (PT) (INR< 1.3), no clinical symptoms or signs of cirrhosis or liver decompensation, and no evidence of cirrhosis as identified by ultrasound or any other procedures within 6 months before study entry.
  • Treatment naïve: never received interferon, ribavirin or any other HCV treatment.
  • No other form of chronic liver disease apart from chronic hepatitis C infection.
  • Hemoglobin ≥ 13 g/dL in men or ≥ 12 g/dL in women, white blood cell (WBC) count ≥ 3,500/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 90,000/mm3; renal biochemistry estimated glomerular filtration rate (eGFR) > 60 mL/min.
  • Be able to attend all scheduled visits and to comply with all study procedures.
  • Be able to provide written informed consent.

Who cannot join

  • Clinically significant illness or surgery within 4 weeks prior to dosing.
  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening besides serum ALT/AST (≤ 5 times the upper limit of normal).
  • 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 (HBsAg) or human immunodeficiency virus (HIV) at screening.
  • Clinically significant vital sign abnormalities at screening.
  • Significant or major fundoscopic findings including but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, microaneurysms and macular changes.
Show all 20Show fewer
  • History of significant alcohol or drug abuse within one year prior to the screening visit (alcohol consumption of more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or refusal to abstain from alcohol or illicit drugs throughout the study.
  • Pregnancy or, in women of child-bearing potential or in spouses of such women, unwillingness or inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicides, or birth control pills, or intrauterine devices throughout the study.
  • History of severe allergic or hypersensitivity reactions (like angioedema), specifically asthma, any known reaction to the study medication, allergic skin rash or other allergic reactions (like anaphylaxis), including severe drug allergies.
  • Therapy with any systemic anti-viral, anti-neoplastic, and immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug.
  • Use of an investigational drug within the last 4 weeks from first dose of this study.
  • Clinically significant gastrointestinal pathology (eg, chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (eg, diarrhea, vomiting), liver (other than CHC) or 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.
  • Any clinically significant history or presence of major or poorly controlled psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt), neurological, cardiovascular, pulmonary (including but not limited to chronic obstructive lung disease), hematological, immunologic, endocrine, metabolic or other uncontrolled systemic disease, coagulation disorders or blood dyscrasias.
  • A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraception.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
  • 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); however, subjects who are cancer survivors not on maintenance therapy had no malignant diseases history within the past 5 years could be recruited.
  • History of opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia).
  • Serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within the 3 months prior to screening.
  • Inability to comprehend the written consent form.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Taiwan13 sites

  • Changhua Christian Hospital

    Changhua, 500

  • National Taiwan University Hospital - Yunlin

    Douliu, 640

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Medical Foundation - Kaohsiung

    Kaohsiung City, 833

  • Chang Gung Medical Foundation - Keelung

    Keelung, 204

  • Chang Gung Medical Foundation - Linkou

    Linkou District, 333

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • Buddhist Tzu Chi General Hospital

    Sindian City, 231

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital

    Taipei, 100

  • Cathay General Hospital

    Taipei, 106

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

About this study

Official title: An Open-label, Randomized, Active Control Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of P1101 + Ribavirin in Treatment-Naïve Subjects With HCV Genotype 1 Infection

Primary objectives:

The purpose of this study is to determine and compare the sustained virologic response (SVR, undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups.

To determine and compare the safety and tolerability of P1101 + Ribavirin across treatment groups.

Being tested
PEGASYS 180 µg Q1W, P1101 180 µg Q1W, 48 doses, P1101 270µg Q1W, 48 doses, P1101 450µg Q2W, 24 doses
Keywords
Hepatitis C, Chronic, Interferon-alpha, Hepatitis C Virus
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEGASYS 180 µg Q1WBiological

    48 doses, solution, 48 weeks

  • P1101 180 µg Q1W, 48 dosesBiological

    48 doses, solution, 48 weeks

  • P1101 270µg Q1W, 48 dosesBiological

    48 doses, solution, 48 weeks

  • P1101 450µg Q2W, 24 dosesBiological

    24 doses, solution, 48 weeks

Study groups in NCT01587586
Study groupRoleWhat they receive
PEGASYS 180 µg Q1W + ribavirin* for 48 weeksActive comparatorPegasys 180 µg Q1W(subcutaneous injection)+Ribavirin, multiple doses(48)
Receives: Biological: PEGASYS 180 µg Q1W
P1101 180 µg Q1W + ribavirin* for 48 weeksExperimentalP1101 180 µg Q1W(subcutaneous injection)with Ribavirin, multiple doses
Receives: Biological: P1101 180 µg Q1W, 48 doses
P1101 270 µg Q1W + ribavirin* for 48 weeksExperimentalP1101 270 µg Q1W(subcutaneous injection)+Ribavirin, multiple doses
Receives: Biological: P1101 270µg Q1W, 48 doses
P1101 450 µg Q2W + ribavirin* for 48 weeksExperimentalP1101 450 µg Q2W(subcutaneous injection)+Ribavirin, multiple doses
Receives: Biological: P1101 450µg Q2W, 24 doses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained Virologic Response

    Percentage of subjects with sustained virologic response (SVR, undetectable HCV RNA at follow up week 24) across treatment groups.

    Measured: Follow up week 24 across treatment groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2012 (estimated)
  2. Study start18 Oct 2011
  3. Primary completion22 Nov 2016
  4. Study completion22 Nov 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01587586
Sponsor's protocol ID
A11-201
Status last verified
Oct 2021
First submitted
26 Apr 2012
Last updated
15 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lin HH, Hsu SJ, Lu SN, Chuang WL, Hsu CW, Chien RN, Yang SS, Su WW, Wu JC, Lee TH, Peng CY, Tseng KC, Qin A, Huang YW, Chen PJ. Ropeginterferon alfa-2b in patients with genotype 1 chronic hepatitis C: Pharmacokinetics, safety, and preliminary efficacy. JGH Open. 2021 Jul 10;5(8):929-940. doi: 10.1002/jgh3.12613. eCollection 2021 Aug.

    PubMed 34386602

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEGASYS 180 µg Q1W, P1101 180 µg Q1W, 48 doses and P1101 270µg Q1W, 48 doses in people with Hepatitis C, Chronic, run by PharmaEssentia at 13 sites in Taiwan.

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 8 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Sustained Virologic Response (time frame: Follow up week 24 across treatment groups). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01587586, which also lists 1 linked publication.

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 15 Oct 2021.

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