Trial Outcomes & Findings for A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection (NCT NCT01767116)
NCT ID: NCT01767116
Last Updated: 2021-07-12
Results Overview
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
419 participants
Primary outcome timeframe
12 weeks after last dose of study drug
Results posted on
2021-07-12
Participant Flow
Participant milestones
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
210
|
209
|
|
Overall Study
COMPLETED
|
208
|
207
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection
Baseline characteristics by cohort
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=210 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=209 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
Total
n=419 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 11.94 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 12.03 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after last dose of study drugPopulation: All randomized participants who received at least 1 dose of study drug (intent-to-treat \[ITT\] population); participants with missing data were counted as non-responders.
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN).
Outcome measures
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=210 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=209 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate
|
99.5 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after last dose of study drugPopulation: All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.
Outcome measures
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=210 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=209 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV
|
99.5 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12 (End of Treatment)Population: All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.
The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to \< LLN at the end of treatment.
Outcome measures
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=207 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=205 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
|
51.2 percentage of participants
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after last dose of study drugPopulation: All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.
The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV.
Outcome measures
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=210 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=209 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate
|
99.5 percentage of particpants
|
100 percentage of particpants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12Population: All randomized participants who received at least 1 dose of study drug (ITT population).
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log10 IU/mL above the lowest value post baseline\] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment).
Outcome measures
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=210 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=209 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure During Treatment
Rebound
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Failure During Treatment
Failure to suppress
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)Population: All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA \< LLOQ at the final treatment visit and completed treatment.
Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.
Outcome measures
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=208 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=207 Participants
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Relapse After Treatment
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
ABT-450/r/ABT-267 and ABT-333, Plus RBV
Serious events: 4 serious events
Other events: 133 other events
Deaths: 0 deaths
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
Serious events: 4 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=210 participants at risk
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=209 participants at risk
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.48%
1/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.00%
0/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.48%
1/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.00%
0/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.48%
1/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.48%
1/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTRADUCTAL PROLIFERATIVE BREAST LESION
|
0.00%
0/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.48%
1/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.48%
1/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.00%
0/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Reproductive system and breast disorders
EPIDIDYMITIS
|
0.48%
1/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.00%
0/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.48%
1/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
Other adverse events
| Measure |
ABT-450/r/ABT-267 and ABT-333, Plus RBV
n=210 participants at risk
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
n=209 participants at risk
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.7%
14/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
0.48%
1/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.2%
11/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
2.9%
6/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.3%
9/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
6.2%
13/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.7%
14/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
4.3%
9/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Gastrointestinal disorders
NAUSEA
|
11.0%
23/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
4.3%
9/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
General disorders
ASTHENIA
|
10.5%
22/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
5.7%
12/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
General disorders
FATIGUE
|
21.4%
45/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
23.4%
49/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Nervous system disorders
HEADACHE
|
24.3%
51/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
23.4%
49/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Psychiatric disorders
INSOMNIA
|
9.0%
19/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
3.3%
7/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
9.0%
19/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
2.4%
5/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
11.9%
25/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
5.3%
11/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.7%
12/210 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
3.8%
8/209 • AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
|
Additional Information
Global Medical Information
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER