Chronic Hepatitis CPhase 2NCT01314261

Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

A Phase 2 study testing ABT-267, Pegylated interferon (pegIFN) and Ribavirin (RBV) in people with Chronic Hepatitis C and Hepatitis C Virus (HCV) Infection, run by AbbVie (prior sponsor, Abbott) at 11 sites in 2 countries.

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

The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis C, Hepatitis C Virus (HCV) Infection
What is being tested?: ABT-267, Pegylated interferon (pegIFN) and Ribavirin (RBV)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 11 sitesin 2 countries
Study dates: Mar 2011to Feb 2013
Phase: Phase 2
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Treatment naïve participants
Females must be either postmenopausal for at least 2 years or surgically sterile
Males must be surgically sterile or practicing specific forms of birth control
Chronic hepatitis C virus (HCV), genotype-1 infected participants
Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis

Who cannot join

Pregnant or breastfeeding female
Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
Current or past clinical evidence of cirrhosis or bridging fibrosis
Abnormal screening laboratory results

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States10 sites

Site Reference ID/Investigator# 56623
Birmingham, Alabama, 35215
Site Reference ID/Investigator# 48477
Fairfax, Virginia, 22031
Site Reference ID/Investigator# 51498
Honolulu, Hawaii, 96814
Site Reference ID/Investigator# 48471
Houston, Texas, 77030
Site Reference ID/Investigator# 48473
Indianapolis, Indiana, 46202
Site Reference ID/Investigator# 52782
Kansas City, Missouri, 64131
Site Reference ID/Investigator# 48476
Los Angeles, California, 90048
Site Reference ID/Investigator# 51345
Orlando, Florida, 32809
Site Reference ID/Investigator# 48474
San Antonio, Texas, 78215
Site Reference ID/Investigator# 48472
Seattle, Washington, 98101

Other trials in United States

Puerto Rico1 site

Site Reference ID/Investigator# 48483
San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Read the detailed description

The study was a randomized, double blind, placebo controlled study consisting of 2 substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo + pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks. Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and safety.

Conditions: Chronic Hepatitis C, Hepatitis C Virus (HCV) Infection
Being tested: ABT-267, Pegylated interferon (pegIFN), Ribavirin (RBV), Placebo for ABT-267
Medical subject headings: Hepatitis C, Chronic, Hepatitis C, Infections

What participants receive

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

ABT-267Drug
Also called Ombitasvir
5 mg or 25 mg tablets
Pegylated interferon (pegIFN)Drug
Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
Ribavirin (RBV)Drug
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Placebo for ABT-267Other
Participants received matching placebo tablet at each dose level for ABT-267.

Study groups in NCT01314261
Study group	Role	What they receive
ABT-267 (5 mg) once daily + pegIFN/RBV	Experimental	Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Receives: Drug: ABT-267; Drug: Pegylated interferon (pegIFN); Drug: Ribavirin (RBV)
ABT-267 (50 mg) once daily + pegIFN/RBV	Experimental	Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Receives: Drug: ABT-267; Drug: Pegylated interferon (pegIFN); Drug: Ribavirin (RBV)
ABT-267 (200 mg) once daily + pegIFN/RBV	Experimental	Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Receives: Drug: ABT-267; Drug: Pegylated interferon (pegIFN); Drug: Ribavirin (RBV)
Placebo + pegIFN/RBV	Placebo comparator	Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Receives: Drug: Pegylated interferon (pegIFN); Drug: Ribavirin (RBV); Other: Placebo for ABT-267

What is being measured

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

Percentage of Participants With 4-week Rapid Virologic Response (RVR)
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.
Measured: Week 4
Maximum Plasma Concentration (Cmax) of ABT-267
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Measured: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Time to Maximum Plasma Concentration (Tmax) of ABT-267
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Measured: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Measured: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12
Plasma Concentrations of Ribavirin (RBV)
Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).
Measured: At each study visit from Week 1 to Week 12
Serum Concentrations of Pegylated Interferon (pegIFN)
Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).
Measured: At each study visit from Week 1 to Week 12

Secondary outcomes (6)

Percentage of Participants With Partial Early Virologic Response (pEVR)
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR.
Measured: Baseline and Week 12
Percentage of Participants With Complete Early Virologic Response (cEVR)
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.
Measured: Week 12
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12.
Measured: 12 weeks after the last dose of pegIFN/RBV
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24.
Measured: 24 weeks after the last dose of pegIFN/RBV
Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days.
Measured: Approximately 12 weeks
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR.
Measured: Week 4 through Week 12

Timeline

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

Mar 2011Feb 2013

First posted14 Mar 2011 (estimated)
Study startMar 2011
Primary completionJan 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01314261
Sponsor's protocol ID: M12-114
Status last verified: Jan 2015
First submitted: 11 Mar 2011
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23.
PubMed 26597291

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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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
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All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
ClinicalTrials.gov ID: NCT01314261
Acronym / sponsor ID: M12-114
Conditions: Chronic Hepatitis C, Hepatitis C Virus (HCV) Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jan 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 14 Mar 2011 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
ABT-267 (5 mg) once daily + pegIFN/RBV	Experimental	Drug: ABT-267, Drug: Pegylated interferon (pegIFN), Drug: Ribavirin (RBV)Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267 (50 mg) once daily + pegIFN/RBV	Experimental	Drug: ABT-267, Drug: Pegylated interferon (pegIFN), Drug: Ribavirin (RBV)Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267 (200 mg) once daily + pegIFN/RBV	Experimental	Drug: ABT-267, Drug: Pegylated interferon (pegIFN), Drug: Ribavirin (RBV)Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV	Placebo comparator	Drug: Pegylated interferon (pegIFN), Drug: Ribavirin (RBV), Other: Placebo for ABT-267Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Treatment naïve participants
Females must be either postmenopausal for at least 2 years or surgically sterile
Males must be surgically sterile or practicing specific forms of birth control
Chronic hepatitis C virus (HCV), genotype-1 infected participants
Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis

Key exclusion criteria (5 listed)

Pregnant or breastfeeding female
Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
Current or past clinical evidence of cirrhosis or bridging fibrosis
Abnormal screening laboratory results

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
ABT-267Also: Ombitasvir5 mg or 25 mg tablets	Drug	ABT-267 (200 mg) once daily + pegIFN/RBV, ABT-267 (5 mg) once daily + pegIFN/RBV, ABT-267 (50 mg) once daily + pegIFN/RBV
Pegylated interferon (pegIFN)Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly	Drug	ABT-267 (200 mg) once daily + pegIFN/RBV, ABT-267 (5 mg) once daily + pegIFN/RBV, ABT-267 (50 mg) once daily + pegIFN/RBV, Placebo + pegIFN/RBV
Ribavirin (RBV)200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day	Drug	ABT-267 (200 mg) once daily + pegIFN/RBV, ABT-267 (5 mg) once daily + pegIFN/RBV, ABT-267 (50 mg) once daily + pegIFN/RBV, Placebo + pegIFN/RBV
Placebo for ABT-267Participants received matching placebo tablet at each dose level for ABT-267.	Other	Placebo + pegIFN/RBV

Primary outcome

Percentage of Participants With 4-week Rapid Virologic Response (RVR)
Time frame: Week 4
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.
Maximum Plasma Concentration (Cmax) of ABT-267
Time frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Time to Maximum Plasma Concentration (Tmax) of ABT-267
Time frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267
Time frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Plasma Concentrations of Ribavirin (RBV)
Time frame: At each study visit from Week 1 to Week 12
Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).
Serum Concentrations of Pegylated Interferon (pegIFN)
Time frame: At each study visit from Week 1 to Week 12
Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).

6 secondary outcomes

Percentage of Participants With Partial Early Virologic Response (pEVR)
Time frame: Baseline and Week 12
Percentage of Participants With Complete Early Virologic Response (cEVR)
Time frame: Week 12
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
Time frame: 12 weeks after the last dose of pegIFN/RBV
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
Time frame: 24 weeks after the last dose of pegIFN/RBV
Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)
Time frame: Approximately 12 weeks
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Time frame: Week 4 through Week 12

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABT-267 (5 mg) Once Daily + pegIFN/RBV	9	7
ABT-267 (50 mg) Once Daily + pegIFN/RBV	9	5
ABT-267 (200 mg) Once Daily + pegIFN/RBV	10	7
Placebo + pegIFN/RBV	9	6

Primary outcome: Percentage of Participants With 4-week Rapid Virologic Response (RVR)

Time frame: Week 4. Number. Unit: percentage of participants

Measure	ABT-267 (5 mg) Once Daily + pegIFN/RBV n = 9	ABT-267 (50 mg) Once Daily + pegIFN/RBV n = 9	ABT-267 (200 mg) Once Daily + pegIFN/RBV n = 10	Placebo + pegIFN/RBV n = 9
Value	33.3	55.6	70.0	22.2

ABT-267 (5 mg) Once Daily + pegIFN/RBV vs Placebo + pegIFN/RBV: p = 0.336, Regression, Logistic
ABT-267 (50 mg) Once Daily + pegIFN/RBV vs Placebo + pegIFN/RBV: p = 0.171, Regression, Logistic
ABT-267 (200 mg) Once Daily + pegIFN/RBV vs Placebo + pegIFN/RBV: p = 0.030, Regression, Logistic

Population analysed: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.

Primary outcome: Maximum Plasma Concentration (Cmax) of ABT-267

Time frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). Mean (Standard Deviation). Unit: ng/mL

Measure	ABT-267 (5 mg) Once Daily + pegIFN/RBV n = 9	ABT-267 (50 mg) Once Daily + pegIFN/RBV n = 9	ABT-267 (200 mg) Once Daily + pegIFN/RBV n = 9
Value	10.7 (3.73)	148 (80.8)	535 (160)

Population analysed: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.

Primary outcome: Time to Maximum Plasma Concentration (Tmax) of ABT-267

Measure	ABT-267 (5 mg) Once Daily + pegIFN/RBV n = 9	ABT-267 (50 mg) Once Daily + pegIFN/RBV n = 9	ABT-267 (200 mg) Once Daily + pegIFN/RBV n = 9
Value	3.3 (1.0)	3.8 (1.6)	4.2 (1.6)

Population analysed: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.

Primary outcome: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267

Time frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	ABT-267 (5 mg) Once Daily + pegIFN/RBV n = 7	ABT-267 (50 mg) Once Daily + pegIFN/RBV n = 3	ABT-267 (200 mg) Once Daily + pegIFN/RBV n = 4
Value	115 (35.5)	2200 (1090)	6130 (675)

Population analysed: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABT-267 (5 mg) Once Daily + pegIFN/RBV	0 of 9 (0%)	9 of 9 (100%)	Not reported
ABT-267 (50 mg) Once Daily + pegIFN/RBV	0 of 9 (0%)	9 of 9 (100%)	Not reported
ABT-267 (200 mg) Once Daily + pegIFN/RBV	0 of 10 (0%)	8 of 10 (80%)	Not reported
Placebo + pegIFN/RBV	0 of 9 (0%)	9 of 9 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26597291Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23.
Related InfoLink provided by the sponsor.

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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.

Armen Asatryan, MD study director

AbbVie

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 26 Jan 2015). 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 4-week Rapid Virologic Response (RVR) (time frame: Week 4). The study lists 6 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 NCT01314261, 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 2 Jul 2018.