Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (NCT NCT02707952)

Last Updated: 2021-07-16

Results Overview

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

295 participants

Primary outcome timeframe

12 weeks after the last actual dose of study drug

Results posted on

2021-07-16

Participant Flow

Intent-to-treat population: all participants who received at least 1 dose of study drug

Participant milestones

Participant milestones
Measure	Arm A ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Arm B Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Arm C ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	Arm D ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Overall Study STARTED	129	53	103	10
Overall Study Participants Who Received Study Drug	129	52	103	10
Overall Study COMPLETED	127	52	101	10
Overall Study NOT COMPLETED	2	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Arm B Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Arm C ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.
Overall Study Adverse Event	1	0	0
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	0	1	2

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=129 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Arm B n=52 Participants Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Arm C n=103 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	Arm D n=10 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.	Total n=294 Participants Total of all reporting groups
Age, Customized < 65 years	66 participants n=5 Participants	22 participants n=7 Participants	33 participants n=5 Participants	4 participants n=4 Participants	125 participants n=21 Participants
Age, Customized >= 65 years to < 75 years	37 participants n=5 Participants	23 participants n=7 Participants	43 participants n=5 Participants	4 participants n=4 Participants	107 participants n=21 Participants
Age, Customized >= 75 years	26 participants n=5 Participants	7 participants n=7 Participants	27 participants n=5 Participants	2 participants n=4 Participants	62 participants n=21 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	38 Participants n=7 Participants	58 Participants n=5 Participants	6 Participants n=4 Participants	184 Participants n=21 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	14 Participants n=7 Participants	45 Participants n=5 Participants	4 Participants n=4 Participants	110 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: All participants who received at least 1 dose of study drug, excluding participants with the Y93H polymorphism in NS5A at baseline (ITT-PS population); participants with missing data after backwards imputation were imputed as nonresponders.

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Arm A n=106 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Arm B n=52 Participants Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Arm C ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	Arm D ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Percentage of Participants in Arms A and B With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	99.1 percentage of participants	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. 95% CI was calculated using the normal approximation to the binomial distribution.

Outcome measures

Outcome measures
Measure	Arm A n=129 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Arm B Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Arm C ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	Arm D ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	99.2 percentage of participants Interval 97.7 to 100.0	—	—	—

SECONDARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Subpopulations defined as Genotype 1 and 2 infected cirrhotic participants, prior direct acting antiviral agent (DAA) treatment experienced (T-exp) participants, Genotype 3, 4, 5 or 6-infected participants, and participants with severe renal impairment (RI). 95% CI was calculated using the Wilson score method.

Outcome measures

Outcome measures
Measure	Arm A n=103 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Arm B n=10 Participants Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Arm C ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	Arm D ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) HCV GT1 Participants with Compensated Cirrhosis	100 percentage of participants Interval 90.8 to 100.0	—	—	—
Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) HCV GT2 Participants with Compensated Cirrhosis	100 percentage of participants Interval 82.4 to 100.0	—	—	—
Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) DAA Experienced Participants	93.9 percentage of participants Interval 80.4 to 98.3	—	—	—
Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) HCV GT3,4,5 and 6 Participants	83.3 percentage of participants Interval 55.2 to 95.3	—	—	—
Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Participants With Severe RI and with Cirrhosis	100.0 percentage of participants Interval 34.2 to 100.0	—	—	—
Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Participants With Severe RI and without Cirrhosis	—	100 percentage of participants Interval 72.2 to 100.0	—	—

SECONDARY outcome

Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment

Population: All participants who received at least 1 dose of study drug (ITT population).

On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method.

Outcome measures

Outcome measures
Measure	Arm A n=129 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Arm B n=52 Participants Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Arm C n=103 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	Arm D n=10 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants Interval 0.0 to 2.9	0 percentage of participants Interval 0.0 to 6.9	1.0 percentage of participants Interval 0.2 to 5.3	0 percentage of participants Interval 0.0 to 27.8

SECONDARY outcome

Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Population: All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA \<LLOQ at the final treatment visit.

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels \< LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. The confidence interval was calculated using the Wilson score method.

Outcome measures

Outcome measures
Measure	Arm A n=129 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Arm B n=51 Participants Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Arm C n=100 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	Arm D n=10 Participants ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Percentage of Participants With Post-Treatment Relapse	0 percentage of participants Interval 0.0 to 2.9	0 percentage of participants Interval 0.0 to 7.0	3.0 percentage of participants Interval 1.0 to 8.5	0 percentage of participants Interval 0.0 to 27.8

Adverse Events

ARM A

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

ARM B

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

ARM C

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

ARM D

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ARM A n=129 participants at risk ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype(GT)1 -infected, DAA treatment-naïve participants without cirrhosis.	ARM B n=52 participants at risk Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	ARM C n=103 participants at risk ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	ARM D n=10 participants at risk ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Gastrointestinal disorders CONSTIPATION	0.00% 0/129 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/103 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders CHOLANGITIS ACUTE	0.00% 0/129 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/103 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.00% 0/129 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/103 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications STERNAL FRACTURE	0.00% 0/129 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/103 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/129 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/103 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders FLUID OVERLOAD	0.00% 0/129 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/103 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.00% 0/129 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/103 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Other adverse events

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