Hepatitis CPhase 1NCT02063607

The Study of Safety, Pharmacokinetics, Pharmacodynamics of Peglamda (Peginterferon Lamda 1) on Healthy Volunteers and the Preliminary Evaluation of Peglamda and Hepasig (Ribavirin) Treatment's Effects on Chronic Hepatitis C Patients

A Phase 1 study testing Peginterferon lambda in people with Hepatitis C, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.

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

This is an open label, dose ranging, phase1a/1b clinical trial to study the safety, Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy volunteers and antiviral activity of once weekly Peglamda administration in combination with daily Ribavirin in Hepatitis C naive patients up to 4… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis C
What is being tested?: Peginterferon lambda
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteVietnam
Study dates: Dec 2013to Jul 2016
Phase: Phase 1
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Phase 1a: The subjects who are willing to participate in Phase 1a study must meet ALL of the following inclusion criteria:
Volunteers (male and female) between the ages of 18-45
Women have a negative pregnancy test result at the time of study.
Clinical examination and result laboratory for 7 days before starting the trial must be inside the normal range.
Currently not following any treatment regimen (except for using the oral contraceptive).
Body mass index is between the range and / or not 25% difference compared to the normal BMI (Appendix 6).

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Be able to comply with protocol and exchange information effectively with the researchers, agree on the written informed consent to participate in the clinical trial
Phase 1b: Subjects willing to participate into the phase 1b study must meet ALL of the following inclusion criteria:
Patients with chronic hepatitis C (male and female).
Ages between 18 - 65 years old.
Female patient (or female partners of the male patients) with negative pregnancy test results and/or apply effective contraception if still having sex during the study and for 6 months after using the last dose of Ribavirin.
No previous treatment with IFN or IFN treatment with rapid viral response or already have completely viral response but leave the treatment early.
HCV-RNA levels in serum > 80 IU / mL.
The haematological and biochemical (except ALT / AST) parameters must be within normal limits.
Body weight in the normal range of 25% difference compared to the normal BMI (Appendix 6)
Be able to comply with protocol and exchange information effectively with the researchers, agree on the written informed consent to participate in the clinical trial

Who cannot join

Phase 1a: Subjects with at least 1 of the following exclusion criteria are considered ineligible to participate in Phase 1a study:
With a history of drug abuse, alcohol or drug using within 1 year before taking part in the clinical trial. AUDIT-C scale (WHO) will be used to assess the use of alcohol. The score ≥ 4 in men or ≥ 3 in women are considered as alcoholics.
History of depression
History of chronic diseases related to the respiratory system, cardiovascular, gastrointestinal, malignant disease affecting to the function of the organ systems. Having any interferon or antiviral therapy within 4 months before the trial
Participate in any clinical trial within 3 months prior the testing
Use of any drug in the last period of relatively positive test which last approximately 6 times the half-life of the drug.

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Blood donor with more than 400 mL of blood within 3 months prior the testing
Influenza infection or cold symptoms within 2 weeks before the trial
Having positive tests of HBV, HCV or HIV
Breastfeeding women
Phase 1b: Subjects with at least 1 of the following exclusion criteria are considered ineligible to participate in Phase 1b study:
Co-infection with hepatitis B and/or HIV.
Hepatic Impairment
Cirrhosis
Positive tests with antibody of Peginterferon lambda 1 and Peginterferon alpha 2a.
History of chronic diseases related to the respiratory system, cardiovascular, gastrointestinal, malignant disease affecting to the function of the organ systems.
A history of immune disorders (eg, inflammatory bowel disease, hemorrhagic thrombocythemia, lupus erythematosus, autoimmune hemolytic anemia, autoimmune disease, scleroderma, severe psoriasis, arthritis rheumatoid ...)
A history of severe mental illness, especially depression, especially the serious neurological condition determined as depression or serious psychological disorders, suicidal intention, or being hospitalized for mental illness, or having 1 phase of impaired function due to neuropathy.
A history of severe epilepsy or using antiepileptic drugs.
A history of using anti-cancer agents (including radiation therapy) or immunotherapy (including systematic corticosteroids) within 6 months before using the first testing dose or the patient may be in need of this treatment during the trial
History of organ transplants with the presence of the graft function.
Evidence of alcohol or drugs abuse within 1 year before the trial. AUDIT scale - C will be used to assess the use of alcohol. The score ≥ 4 in men or ≥ 3 in women are considered as alcoholics
History or evidence of severe disease or any other condition based on the investigator assessment that the subject may not be suitable for this study.
Breastfeeding women.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

The Military 108 Hospital
Hanoi, 10000

Other trials in Vietnam

About this study

Official title: The Phase 1a/1b Study of Safety, Pharmacokinetics, Pharmacodynamics of Peglamda (Peginterferon Lamda 1) on Healthy Volunteers and the Preliminary Evaluation of Peglamda and Hepasig (Ribavirin) Treatment's Effects on Chronic Hepatitis C Patients

Conditions: Hepatitis C
Being tested: Peginterferon lambda
Keywords: Hepatitis C naive
Medical subject headings: Hepatitis C

What participants receive

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

Peginterferon lambdaBiological

Study groups in NCT02063607
Study group	Role	What they receive
Peginterferon alfa 2a	Active comparator	Peginterferon alfa 2a 180 mcg Receives: Biological: Peginterferon lambda
Peginterferon Lambda	Experimental	Peginterferon Lambda 60,120,180 and 240 mcg Receives: Biological: Peginterferon lambda

What is being measured

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

Area Under the Concentration-Time Curve (AUC 0-336)
Measured: 0, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 336 hours
Percentage of Patients achieving Rapid Virological Response (RVR)
Measured: 4 weeks

Secondary outcomes (1)

Number of subjects with incidence of adverse events
Measured: 15 days

Timeline

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

Dec 2013Jul 2016

First posted14 Feb 2014 (estimated)
Study startDec 2013
Primary completionFeb 2015
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis CStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02063607
Sponsor's protocol ID: NNG01
Status last verified: Feb 2014
First submitted: 11 Feb 2014
Last updated: 15 Dec 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Phase 1a/1b Study of Safety, Pharmacokinetics, Pharmacodynamics of Peglamda (Peginterferon Lamda 1) on Healthy Volunteers and the Preliminary Evaluation of Peglamda and Hepasig (Ribavirin) Treatment's Effects on Chronic Hepatitis C Patients
ClinicalTrials.gov ID: NCT02063607
Acronym / sponsor ID: NNG01
Conditions: Hepatitis C
Keywords: Hepatitis C naive
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Feb 2015 (actual)
Study completion: Jul 2016 (actual)
First posted: 14 Feb 2014 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Peginterferon alfa 2a	Active comparator	Biological: Peginterferon lambdaPeginterferon alfa 2a 180 mcg
Peginterferon Lambda	Experimental	Biological: Peginterferon lambdaPeginterferon Lambda 60,120,180 and 240 mcg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Phase 1a: The subjects who are willing to participate in Phase 1a study must meet ALL of the following inclusion criteria:
Volunteers (male and female) between the ages of 18-45
Women have a negative pregnancy test result at the time of study.
Clinical examination and result laboratory for 7 days before starting the trial must be inside the normal range.
Currently not following any treatment regimen (except for using the oral contraceptive).

Key exclusion criteria (24 listed)

Phase 1a: Subjects with at least 1 of the following exclusion criteria are considered ineligible to participate in Phase 1a study:
With a history of drug abuse, alcohol or drug using within 1 year before taking part in the clinical trial. AUDIT-C scale (WHO) will be used to assess the use of alcohol. The score ≥ 4 in men or ≥ 3 in women are considered as alcoholics.
History of depression
History of chronic diseases related to the respiratory system, cardiovascular, gastrointestinal, malignant disease affecting to the function of the organ systems. Having any interferon or antiviral therapy within 4 months before the trial
Participate in any clinical trial within 3 months prior the testing

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
Peginterferon lambda	Biological	Peginterferon Lambda, Peginterferon alfa 2a

Primary outcome

Area Under the Concentration-Time Curve (AUC 0-336)
Time frame: 0, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 336 hours
Percentage of Patients achieving Rapid Virological Response (RVR)
Time frame: 4 weeks

1 secondary outcome

Number of subjects with incidence of adverse events
Time frame: 15 days

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 15 Dec 2016.
Individual participant dataSharing planned: No

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

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.

Dr.Chinh Trong Nguyen, PhD principal investigator

The Military 108 Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Peginterferon lambda in people with Hepatitis C, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.

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 16 inclusion and 24 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Area Under the Concentration-Time Curve (AUC 0-336) (time frame: 0, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 336 hours). The study lists 2 primary outcomes in all. 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 NCT02063607.

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 Dec 2016.