A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

NCT01074008 | Completed Phase 2 Results

• 1 other identifier: M11-602
• Study Type: interventional
• Target: 74
• Locations: 2 countries
• Sites: 26

Brief Summary

This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.

Conditions

Hepatitis C; HCV; Chronic Hepatitis C Infection; Hepatitis C Genotype 1

Outcome Measures

Primary Outcomes (13)

• Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment

  Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.

  Prior to dosing on Day 1 to before the morning dose on Day 4

• Maximum Plasma Concentration (Cmax) of ABT-450

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-450

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-450 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-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-450

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

• Maximum Plasma Concentration (Cmax) of Ritonavir

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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 ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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 Ritonavir

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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 ritonavir 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 ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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 Ritonavir

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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 ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

• Maximum Plasma Concentration (Cmax) of ABT-072

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-072

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-072 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-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-072

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

• Maximum Plasma Concentration (Cmax) of ABT-333

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-333

  Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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-333 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-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 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 12 Hours (AUC12) Post-dose of ABT-333

  Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

  Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1

Secondary Outcomes (3)

• Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

  Week 4

• Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12

  Baseline and Week 12

• Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12

  Week 12

Other Outcomes (8)

• Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)

  Baseline and Day 4

• Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)

  Baseline and Day 4

• Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)

  Baseline and Day 4

Study Arms (9)

ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV

EXPERIMENTAL

Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: ABT-450; Drug: Ritonavir; Drug: Peginterferon alpha-2a; Drug: Ribavirin

ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV

EXPERIMENTAL

Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: ABT-450; Drug: Ritonavir; Drug: Peginterferon alpha-2a; Drug: Ribavirin

ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV

EXPERIMENTAL

Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: ABT-450; Drug: Ritonavir; Drug: Peginterferon alpha-2a; Drug: Ribavirin

ABT-072 (100 mg) once daily (QD) + pegIFN/RBV

EXPERIMENTAL

Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: ABT-072; Drug: Peginterferon alpha-2a; Drug: Ribavirin

ABT-072 (300 mg) once daily (QD) + pegIFN/RBV

EXPERIMENTAL

Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: ABT-072; Drug: Peginterferon alpha-2a; Drug: Ribavirin

ABT-072 (600 mg) once daily (QD) + pegIFN/RBV

EXPERIMENTAL

Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: ABT-072; Drug: Peginterferon alpha-2a; Drug: Ribavirin

ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV

EXPERIMENTAL

Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: ABT-333; Drug: Peginterferon alpha-2a; Drug: Ribavirin

ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV

EXPERIMENTAL

Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: ABT-333; Drug: Peginterferon alpha-2a; Drug: Ribavirin

Placebo + pegIFN/RBV

PLACEBO COMPARATOR

Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.

Drug: Peginterferon alpha-2a; Drug: Ribavirin; Other: Placebo

Interventions

ABT-450 DRUG

50 mg capsules co-administered with ritonavir

ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV; ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV; ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV

ABT-072 DRUG

50 mg tablet

ABT-072 (100 mg) once daily (QD) + pegIFN/RBV; ABT-072 (300 mg) once daily (QD) + pegIFN/RBV; ABT-072 (600 mg) once daily (QD) + pegIFN/RBV

ABT-333 DRUG

400 mg tablet

Also known as: Dasabuvir

ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV; ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV

Ritonavir DRUG

100 mg capsules co-administered with ABT-450

Also known as: ABT-538, Norvir

ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV; ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV; ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV

Peginterferon alpha-2a DRUG

Syringe, 180 µg/0.5 mL for subcutaneous injections

ABT-072 (100 mg) once daily (QD) + pegIFN/RBV; ABT-072 (300 mg) once daily (QD) + pegIFN/RBV; ABT-072 (600 mg) once daily (QD) + pegIFN/RBV; ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV; ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV; ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV; ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV; ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV; Placebo + pegIFN/RBV

Ribavirin DRUG

200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day

ABT-072 (100 mg) once daily (QD) + pegIFN/RBV; ABT-072 (300 mg) once daily (QD) + pegIFN/RBV; ABT-072 (600 mg) once daily (QD) + pegIFN/RBV; ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV; ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV; ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV; ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV; ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV; Placebo + pegIFN/RBV

Placebo OTHER

Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level

Placebo + pegIFN/RBV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C virus (HCV), genotype 1 infection (HCV ribonucleic acid level greater than or equal to 100,000 IU/mL) at screening
• Liver biopsy within 3 years with histology consistent with HCV-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV
• Treatment naïve male or female between the ages of 18 and 65
• Females must be post-menopausal for more than 2 years or surgically sterile
• Negative screen for drugs and alcohol
• Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus antibodies (anti-HIV Ab)
• No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers or inhibitors within 1 month of dosing
• Be in a condition of general good health, as perceived by the investigator, other than HCV infection

You may not qualify if:

• Significant sensitivity to any drug
• Use of herbal supplements within 2 weeks prior to study drug dosing
• History of major depression within 2 years
• Prior treatment with any investigational or commercially available anti-HCV agents
• Abnormal laboratory tests

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (26)

Site Reference ID/Investigator# 23392

Phoenix, Arizona, 85054, United States

Location

Site Reference ID/Investigator# 23370

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 23387

La Jolla, California, 92037, United States

Location

Site Reference ID/Investigator# 23388

Los Angeles, California, 90048, United States

Location

Site Reference ID/Investigator# 23371

Aurora, Colorado, 80045, United States

Location

Site Reference ID/Investigator# 23369

Orlando, Florida, 32803, United States

Location

Site Reference ID/Investigator# 26362

Orlando, Florida, 32809, United States

Location

Site Reference ID/Investigator# 23373

Chicago, Illinois, 60611, United States

Location

Site Reference ID/Investigator# 24908

Chicago, Illinois, 60612, United States

Location

Site Reference ID/Investigator# 23381

Indianapolis, Indiana, 46202-5121, United States

Location

Site Reference ID/Investigator# 23372

Baton Rouge, Louisiana, 70810, United States

Location

Site Reference ID/Investigator# 24710

New Orleans, Louisiana, 70112, United States

Location

Site Reference ID/Investigator# 23391

Baltimore, Maryland, 21287, United States

Location

Site Reference ID/Investigator# 23377

Detroit, Michigan, 48202, United States

Location

Site Reference ID/Investigator# 24909

Saint Paul, Minnesota, 55114, United States

Location

Site Reference ID/Investigator# 35842

New York, New York, 10016, United States

Location

Site Reference ID/Investigator# 23379

New York, New York, 10021, United States

Location

Site Reference ID/Investigator# 23375

Chapel Hill, North Carolina, 27599-7584, United States

Location

Site Reference ID/Investigator# 23385

Durham, North Carolina, 27705, United States

Location

Site Reference ID/Investigator# 23376

Dallas, Texas, 75203, United States

Location

Site Reference ID/Investigator# 24891

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 23382

San Antonio, Texas, 78215, United States

Location

Site Reference ID/Investigator# 24715

Salt Lake City, Utah, 84132-2410, United States

Location

Site Reference ID/Investigator# 25463

Seattle, Washington, 98101, United States

Location

Site Reference ID/Investigator# 23383

Madison, Wisconsin, 53792, United States

Location

Site Reference ID/Investigator# 23363

Ponce, 00731, Puerto Rico

Location

Related Publications (1)

• Pilot-Matias T, Tripathi R, Cohen D, Gaultier I, Dekhtyar T, Lu L, Reisch T, Irvin M, Hopkins T, Pithawalla R, Middleton T, Ng T, McDaniel K, Or YS, Menon R, Kempf D, Molla A, Collins C. In vitro and in vivo antiviral activity and resistance profile of the hepatitis C virus NS3/4A protease inhibitor ABT-450. Antimicrob Agents Chemother. 2015 Feb;59(2):988-97. doi: 10.1128/AAC.04227-14. Epub 2014 Dec 1.

  PMID: 25451053 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C

Interventions

paritaprevir; ABT-072; dasabuvir; Ritonavir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Daniel Cohen

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 8, 2015
• Results First Posted: January 8, 2015

Record last verified: 2014-12

Locations

PR (1); US (25)