A Phase 2/3 interventional study of ABT-450/r/ABT-267 and ABT-333 in Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection and Chronic Hepatitis C, sponsored by AbbVie. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by AbbVie · Phase 2/3, Interventional, and Treatment
The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment.
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Exclusion Criteria:
ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: ribavirin
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: ribavirin
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: ribavirin
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: ribavirin
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for noncirrhotic (at screening) GT1b-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: ribavirin
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-experienced participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: ribavirin
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for noncirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: ribavirin
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for cirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: ribavirin
ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
Drug: ABT-450/r/ABT-267 · Drug: ribavirin
ABT-450/r/ABT-267 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
Drug: ABT-450/r/ABT-267 · Drug: ribavirin
tablet
Also known as: ombitasvir/paritaprevir/ritonavir, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
tablet
Also known as: Dasabuvir
tablet
Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution. The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants in Part 1a Achieving SVR12
SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
Time frame: 12 weeks after last dose of study drug
Percentage of Participants in Part 1b Achieving SVR12
SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
Time frame: 12 weeks after last dose of study drug
Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12
SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
Time frame: 12 weeks after last dose of study drug
Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall
SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
Time frame: 12 weeks after last dose of study drug
Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period
Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
Time frame: up to 12 or 24 weeks, based on treatment duration
Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period
Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
Time frame: up to 12 weeks
Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period
Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
Time frame: up to 12 or 24 weeks, based on treatment duration
Percentage of Participants in Part 1a With Relapse12
Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA \< LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.
Time frame: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug
Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall
Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA \< LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.
Time frame: up to 12 weeks after the last actual dose of study drug
Percentage of Participants in Part 2 With Relapse12
Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA \< LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA \< LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.
Time frame: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug
Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).
Time frame: End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126)
Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).
Time frame: End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)
Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).
Time frame: End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)
Part 2 was not designed to test different treatments on the same subject population. Rather, the arms in Part 2 represent subpopulations with different baseline characteristics (hepatitis C virus \[HCV\] genotype \[GT\], cirrhotic status, prior HCV therapy experience). Arms F and G were randomized to regimens without and with ribavirin, respectively.
| Milestone | Part 1a: Arm A | Part 1a: Arm B | Part 1b: Arm C | Part 1b: Arm D | Part 2: GT1 Analysis Group | Part 2: Arm G | GT4 Analysis Group |
|---|---|---|---|---|---|---|---|
| Started | 31 | 32 | 10 | 12 | 200 | 5 | 28 |
| Completed | 30 | 31 | 10 | 11 | 196 | 4 | 26 |
| Not completed | 1 | 1 | 0 | 1 | 4 | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 | 3 | 1 | 2 |
SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution. The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).
| percentage of participants | Part 2: GT1 Analysis Group |
|---|---|
| Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) | 97.0 (93.6 to 98.6) |
SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
| percentage of participants | Part 1a: Arm A | Part 1a: Arm B |
|---|---|---|
| Percentage of Participants in Part 1a Achieving SVR12 | 93.5 (79.3 to 98.2) | 90.6 (75.8 to 96.8) |
SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
| percentage of participants | Part 1b: Arm C | Part 1b: Arm D | Part 1b: Total |
|---|---|---|---|
| Percentage of Participants in Part 1b Achieving SVR12 | 100 (72.2 to 100.0) | 100 (75.8 to 100.0) | 100 (85.1 to 100.0) |
SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
| percentage of participants | Part 2: Arm F | Part 2: Arm G |
|---|---|---|
| Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12 | 75.0 (30.1 to 95.4) | 80.0 (37.6 to 96.4) |
SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
| percentage of participants | Part 2: GT4 Analysis Group | Part 2: Arm K |
|---|---|---|
| Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall | 96.4 (82.3 to 99.4) | 96.4 (82.3 to 99.4) |
Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
| percentage of participants | Part 1a: Arm A | Part 1a: Arm B |
|---|---|---|
| Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period | 0 (0.0 to 11.0) | 3.1 (0.6 to 15.7) |
Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
| percentage of participants | Part 1b: Arm C | Part 1b: Arm D | Part 1b: Total |
|---|---|---|---|
| Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period | 0 (0.0 to 27.8) | 0 (0.0 to 24.2) | 0 (0.0 to 14.9) |
Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
| percentage of participants | Part 2: GT1 Analysis Group | Part 2: Arm E | Part 2: Arm F | Part 2: Arm I | Part 2: Arm J | Part 2: GT4 Analysis Group | Group 2: Arm K |
|---|---|---|---|---|---|---|---|
| Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period | 0.5 (0.1 to 2.8) | 0 (0.0 to 8.4) | 25.0 (4.6 to 69.9) | 0 (0.0 to 2.8) | 0 (0.0 to 16.8) | 0 (0.0 to 12.1) | 0 (0.0 to 12.1) |
Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA \< LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.
| percentage of participants | Part 1a: Arm A | Part 1a: Arm B |
|---|---|---|
| Percentage of Participants in Part 1a With Relapse12 | 3.3 (0.6 to 16.7) | 0 (0.0 to 11.0) |
Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA \< LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.
| percentage of participants | Part 1b: Arm C | Part 1b: Arm D | Part 1b: Total |
|---|---|---|---|
| Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall | 0 (0.0 to 27.8) | 0 (0.0 to 24.2) | 0 (0.0 to 14.9) |
Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA \< LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA \< LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.
| percentage of participants | Part 2: GT1 Analysis Group | Part 2: Arm E | Part 2: Arm F | Part 2: Arm I | Part 2: Arm J | Part 2: GT4 Analysis Group | Group 2: Arm K |
|---|---|---|---|---|---|---|---|
| Percentage of Participants in Part 2 With Relapse12 | 0.5 (0.1 to 2.9) | 0 (0.0 to 8.4) | 0 (0.0 to 56.1) | 0.8 (0.1 to 4.2) | 0 (0.0 to 19.4) | 0 (0.0 to 12.5) | 0 (0.0 to 12.5) |
HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).
| percentage of participants | Part 1a: Arm A | Part 1a: Arm B |
|---|---|---|
| End of Treatment | 93.5 (79.3 to 98.2) | 90.6 (75.8 to 96.8) |
| Post-Treatment Week 12 | 96.8 (83.8 to 99.4) | 93.8 (79.9 to 98.3) |
HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).
| percentage of participants | Part 1b: Arm C | Part 1b: Arm D | Part 1b Total |
|---|---|---|---|
| End of Treatment | 100 (72.2 to 100.0) | 83.3 (55.2 to 95.3) | 90.9 (72.2 to 97.5) |
| Post-Treatment Week 12 | 100 (72.2 to 100.0) | 75.0 (46.8 to 91.1) | 86.4 (66.7 to 95.3) |
HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).
| percentage of participants | Part 2: GT1 Analysis Group | Part 2: Arm E | Part 2: Arm F | Part 2: Arm I | Part 2: Arm J | Part 2: GT4 Analysis Group | Group 2: Arm K |
|---|---|---|---|---|---|---|---|
| End of Treatment | 89 (83.9 to 92.6) | 90.5 (77.9 to 96.2) | 100 (51.0 to 100.0) | 89.6 (83.3 to 93.7) | 78.9 (56.7 to 91.5) | 85.7 (68.5 to 94.3) | 85.7 (68.5 to 94.3) |
| Post-Treatment Week 12 | 93 (88.6 to 95.8) | 97.6 (87.7 to 99.6) | 100 (51.0 to 100.0) | 91.9 (86.0 to 95.4) | 89.5 (68.6 to 97.1) | 92.9 (77.4 to 98.0) | 92.9 (77.4 to 98.0) |
Collected over Protocol-related treatment-emergent adverse events were collected from the first dose of study drug through end of treatment Week 12 and Week 24; treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1a: Arm A | — | 0/31 (0%) | 28/31 (90.3%) |
| Part 1a: Arm B | — | 0/32 (0%) | 27/32 (84.4%) |
| Part 1b: Arm C | — | 0/10 (0%) | 10/10 (100%) |
| Part 1b: Arm D | — | 1/12 (8.3%) | 10/12 (83.3%) |
| Part 2: Arm E | — | 1/42 (2.4%) | 23/42 (54.8%) |
| Part 2: Arm F | — | 0/4 (0%) | 3/4 (75%) |
| Part 2: Arm G | — | 0/5 (0%) | 4/5 (80%) |
| Part 2: Arm I | — | 6/135 (4.4%) | 109/135 (80.7%) |
| Part 2: Arm J | — | 2/19 (10.5%) | 18/19 (94.7%) |
| Part 2: Arm K | — | 1/28 (3.6%) | 23/28 (82.1%) |
| Event | Part 1a: Arm A | Part 1a: Arm B | Part 1b: Arm C | Part 1b: Arm D | Part 2: Arm E | Part 2: Arm F | Part 2: Arm G | Part 2: Arm I | Part 2: Arm J | Part 2: Arm K |
|---|---|---|---|---|---|---|---|---|---|---|
| COLITISGastrointestinal disorders | 0/31 | 0/32 | 0/10 | 1/12 | 0/42 | 0/4 | 0/5 | 0/135 | 0/19 | 0/28 |
| DEHYDRATIONMetabolism and nutrition disorders | 0/31 | 0/32 | 0/10 | 1/12 | 0/42 | 0/4 | 0/5 | 0/135 | 0/19 | 0/28 |
| ANAEMIABlood and lymphatic system disorders | 0/31 | 0/32 | 0/10 | 0/12 | 0/42 | 0/4 | 0/5 | 0/135 | 1/19 | 0/28 |
| INFLUENZAInfections and infestations | 0/31 | 0/32 | 0/10 | 0/12 | 0/42 | 0/4 | 0/5 | 0/135 | 1/19 | 0/28 |
| DEPRESSIONPsychiatric disorders | 0/31 | 0/32 | 0/10 | 0/12 | 0/42 | 0/4 | 0/5 | 0/135 | 1/19 | 0/28 |
| URETEROLITHIASISRenal and urinary disorders | 0/31 | 0/32 | 0/10 | 0/12 | 0/42 | 0/4 | 0/5 | 0/135 | 1/19 | 0/28 |
| DRUG DEPENDENCEPsychiatric disorders | 0/31 | 0/32 | 0/10 | 0/12 | 0/42 | 0/4 | 0/5 | 0/135 | 0/19 | 1/28 |
| ANGINA UNSTABLECardiac disorders | 0/31 | 0/32 | 0/10 | 0/12 | 1/42 | 0/4 | 0/5 | 0/135 | 0/19 | 0/28 |
| PERICARDITISCardiac disorders | 0/31 | 0/32 | 0/10 | 0/12 | 0/42 | 0/4 | 0/5 | 1/135 | 0/19 | 0/28 |
| ABDOMINAL PAINGastrointestinal disorders | 0/31 | 0/32 | 0/10 | 0/12 | 0/42 | 0/4 | 0/5 | 1/135 | 0/19 | 0/28 |
| Event | Part 1a: Arm A | Part 1a: Arm B | Part 1b: Arm C | Part 1b: Arm D | Part 2: Arm E | Part 2: Arm F | Part 2: Arm G | Part 2: Arm I | Part 2: Arm J | Part 2: Arm K |
|---|---|---|---|---|---|---|---|---|---|---|
| FATIGUEGeneral disorders | 18/31 | 12/32 | 5/10 | 4/12 | 2/42 | 0/4 | 0/5 | 40/135 | 6/19 | 5/28 |
| HAEMOGLOBIN DECREASEDInvestigations | 3/31 | 0/32 | 1/10 | 4/12 | 0/42 | 0/4 | 0/5 | 13/135 | 6/19 | 4/28 |
| BRONCHITISInfections and infestations | 0/31 | 0/32 | 3/10 | 0/12 | 1/42 | 1/4 | 0/5 | 6/135 | 0/19 | 1/28 |
| IRRITABILITYPsychiatric disorders | 3/31 | 3/32 | 3/10 | 2/12 | 0/42 | 1/4 | 0/5 | 7/135 | 2/19 | 1/28 |
| NAUSEAGastrointestinal disorders | 5/31 | 6/32 | 2/10 | 2/12 | 3/42 | 1/4 | 0/5 | 34/135 | 4/19 | 5/28 |
| ABDOMINAL PAIN UPPERGastrointestinal disorders | 1/31 | 0/32 | 0/10 | 0/12 | 2/42 | 1/4 | 0/5 | 5/135 | 0/19 | 3/28 |
| DIARRHOEAGastrointestinal disorders | 1/31 | 4/32 | 1/10 | 2/12 | 4/42 | 1/4 | 0/5 | 26/135 | 1/19 | 1/28 |
| ASTHENIAGeneral disorders | 0/31 | 0/32 | 0/10 | 1/12 | 1/42 | 1/4 | 0/5 | 13/135 | 2/19 | 3/28 |
| JAUNDICEHepatobiliary disorders | 2/31 | 0/32 | 0/10 | 0/12 | 0/42 | 1/4 | 0/5 | 7/135 | 0/19 | 1/28 |
| PYELONEPHRITISInfections and infestations | 0/31 | 0/32 | 0/10 | 0/12 | 0/42 | 1/4 | 0/5 | 1/135 | 0/19 | 0/28 |
| Age, Customized(Participants) | Part 1a: Arm A | Part 1a: Arm B | Part 1b: Arm C | Part 1b: Arm D | Part 2: GT1 Analysis Group | Part 2: Arm G | Part 2: GT4 Analysis Group | Total |
|---|---|---|---|---|---|---|---|---|
| Age Group — < 55 years | 23 | 20 | 5 | 8 | 145 | 2 | 24 | 227 |
| Age Group — ≥ 55 years | 8 | 12 | 5 | 4 | 55 | 3 | 4 | 91 |
| Sex: Female, Male(Participants) | Part 1a: Arm A | Part 1a: Arm B | Part 1b: Arm C | Part 1b: Arm D | Part 2: GT1 Analysis Group | Part 2: Arm G | Part 2: GT4 Analysis Group | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 2 | 3 | 2 | 3 | 44 | 1 | 2 | 57 |
| Male | 29 | 29 | 8 | 9 | 156 | 4 | 26 | 261 |
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