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Hepatitis CPhase 3NCT01995266

Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

A Phase 3 study testing Asunaprevir and Daclatasvir in people with Hepatitis C, run by Bristol-Myers Squibb at 38 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Asunaprevir and Daclatasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
38 sitesin 3 countries
Study dates
28 Feb 2014to 31 Jul 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Males and females, ≥ 18 years of age
  • Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and either:
  • Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening
  • or
  • Liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation)
  • Subjects who are intolerant to previous therapy with Interferon Alfa (IFNα) either with or without Ribavirin (RBV) (I±R)(independent of previous response to therapy) or ineligible for I±R and who meet one of the criteria below:
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  • Anemia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in hemoglobin to < 8.5 g/dL during therapy (documented); the I±R ineligibles are subjects who have a screening hemoglobin < 10.0 g/dL and ≥ 8.5 g/dL
  • OR
  • Neutropenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in absolute neutrophil count (ANC) to < 0.5 x 10(9) during therapy (documented); the I±R ineligibles are subjects who have a screening ANC < 1.5 x 10(9) cells/L and ≥ 0.5 x 10(9) cells/L
  • OR
  • Thrombocytopenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in platelet counts < 25,000 cells/mm3 during therapy (documented); the I±R ineligibles are subjects who have a screening platelet count of < 90 x 10(9) cells/L and ≥ 50 x 10(9) cells/L
  • HCV RNA ≥ 10,000 IU/mL
  • Seronegative for Human Immunodeficiency Virus (HIV) and hepatitis B surface antigen (HBsAg)
  • Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI = weight (kg)/ [height(m)]2 at screening
  • Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 40%). If a subject does not have cirrhosis, a liver biopsy within three years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. For countries where liver biopsy is not required prior to treatment and where noninvasive imaging tests (Fibroscan® ultrasound) are approved for staging of liver disease, non-invasive imaging test results may be used to assess the extent of liver disease

Who cannot join

  • Prior treatment with HCV direct acting antiviral (DAA)
  • Evidence of a medical condition contributing to chronic liver disease other than HCV
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
  • Diagnosed or suspected hepatocellular carcinoma or other malignancies
  • Uncontrolled diabetes or hypertension
  • History of moderate to severe depression. Well-controlled mild depression is allowed
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  • Total bilirubin ≥ 34 µmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
  • Confirmed alanine aminotransferase (ALT) ≥ 5 x upper limit of normal (ULN)
  • Confirmed albumin < 3.5 g/dL (35 g/L)
  • Alpha-fetoprotein (AFP) > 100 ng/mL OR ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of hepatocellular carcinoma (HCC) are excluded
  • Confirmed hemoglobin < 8.5 g/dL
  • Confirmed ANC < 0.5 x 10(9) cells/L
  • Confirmed platelet count < 50,000 cells/mm3

Trial locations and contacts

38 sites in 3 countries.

38 sites in 3 countries

China26 sites

  • Local Institution

    Beijing, Beijing Municipality, 100015

  • Local Institution

    Beijing, Beijing Municipality, 100034

  • Local Institution

    Beijing, Beijing Municipality, 100050

  • Local Institution

    Beijing, Beijing Municipality, 100054

  • Local Institution

    Beijing, Guangdong, 100039

  • Local Institution

    Beijing, Shanxi, 710038

  • Local Institution

    Beijing, 100039

  • Local Institution

    Changchun, Jilin, 130021

  • Local Institution

    Changsha, Hunan, 410008

  • Local Institution

    Changsha, Hunan, 410011

  • Local Institution

    Chongqing, Guangdong, 400038

  • Local Institution

    Chongqing, 400038

  • Local Institution

    Guangzhou, Guangdong, 510060

  • Local Institution

    Guangzhou, Guangdong, 510515

  • Local Institution

    Guangzhou, Guangdong, 510630

  • Local Institution

    Nanjing, Jiangsu, 210002

  • Local Institution

    Nanjing, Jiangsu, 210003

  • Local Institution

    Nanjing, Jiangsu, 210029

  • Local Institution

    Shanghai, Shanghai Municipality, 200025

  • Local Institution

    Shanghai, Shanghai Municipality, 200235

  • Local Institution

    Shanghai, Shanxi, 710061

  • Local Institution

    Shenyang, Liaoning, 110000

  • Local Institution

    Tianjin, Tianjin Municipality, 300192

  • Local Institution

    Wuhan, Hubei, 430022

  • Local Institution

    Xi'an, Shan3xi, 710038

  • Local Institution

    Xi'an, Shan3xi, 710061

Other trials in China

South Korea8 sites

  • Local Institution

    Busan, Guangdong, 602-715

  • Local Institution

    Busan, 602-715

  • Local Institution

    Daegu, Hunan, 700-712

  • Local Institution

    Daegu, 700-712

  • Local Institution

    Seoul, Beijing, 140-743

  • Local Institution

    Seoul, Guangdong, 137-701

  • Local Institution

    Seoul, 137-701

  • Local Institution

    Seoul, 140-743

Other trials in South Korea

Taiwan4 sites

  • Local Institution

    Kaohsiung City, Guangdong, 807

  • Local Institution

    Kaohsiung City, 807

  • Local Institution

    Tainan, Guangdong, 736

  • Local Institution

    Tainan, 736

Other trials in Taiwan

About this study

Official title: A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin

Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen

Conditions
Hepatitis C
Being tested
Asunaprevir, Daclatasvir
Medical subject headings
Hepatitis C

What participants receive

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

  • AsunaprevirDrug

    Also called BMS-650032

  • DaclatasvirDrug

    Also called BMS-790052

Study groups in NCT01995266
Study groupRoleWhat they receive
Asunaprevir + DaclatasvirExperimentalAsunaprevir 100mg soft capsule by mouth twice daily for 24 weeks and Daclatasvir 60mg tablet by mouth once daily for 24 weeks
Receives: Drug: Asunaprevir; Drug: Daclatasvir

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24)

    SVR was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 24.

    Measured: 24 Weeks after treatment discontinuation (Follow-up Week 24)

Secondary outcomes (9)

  1. Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12)

    SVR12 was defined as HCV RNA < LLOQ target detected or not detected at post-treatment follow-up Week 12. For SVR12, missing HCV RNA data at follow-up Week 12 was imputed using the Next Value Carried Backwards (NVCB) approach.

    Measured: 12 Weeks after treatment discontinuation (Follow-up Week 12)

  2. Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.

    Measured: 7 days after treatment discontinuation

  3. Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24

    Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 24.

    Measured: 24 Weeks after treatment discontinuation (Follow-up Week 24)

  4. Percentage of Participants With HCV RNA< LLOQ Target Not Detected at the End of Treatment (Week 24)

    Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0. The lower and upper limits of quantitation (LOQs) of the assay for HCV GT-1 were 25 IU/mL and 3.91 X10^8 IU/mL, respectively; the limit of detection was ~ 10 IU/mL

    Measured: Week 24 (End-of Treatment)

  5. Number of Participants With Rapid Virologic Response (RVR)

    RVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 4.

    Measured: Treatment Week 4

  6. Percentage of Participants With Complete Early Virologic Response (cEVR)

    cEVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 12.

    Measured: Treatment Week 12

  7. Number of Participants With Extended Rapid Virologic Response (eRVR)

    eRVR was defined as HCV RNA < LLOQ, target not detected at treatment Weeks 4 and 12.

    Measured: Treatment Week 4 and Week 12

  8. Number of Participants With HCV RNA < LLOQ Target Detected or Not Detected at the End of Treatment (Week 24)

    Antiviral efficacy is measured by the number of participants with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at End of Treatment (Week 24)

    Measured: Week 24 (End-of Treatment)

  9. Number of Participants With Virologic Response (VR) at Treatment Week 4 and 12

    VR was defined as HCV RNA < LLOQ, target detected or not detected at specific time points (Week 4 and Week 12)

    Measured: Treatment Week 4 and 12

Timeline

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

  1. First posted26 Nov 2013 (estimated)
  2. Study start28 Feb 2014
  3. Primary completion31 Jul 2015
  4. Study completion31 Jul 2015

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01995266
Sponsor's protocol ID
AI447-036
Status last verified
Aug 2020
First submitted
21 Nov 2013
Last updated
11 Aug 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Asunaprevir and Daclatasvir in people with Hepatitis C, run by Bristol-Myers Squibb at 38 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 15 inclusion and 13 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China, South Korea, 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 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?

Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24) (time frame: 24 Weeks after treatment discontinuation (Follow-up Week 24)). 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 NCT01995266.

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 11 Aug 2020.

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