Back to resultsA Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABBV-3067
Placebo ABBV-3067
ABBV-2222
Placebo ABBV-2222
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, ABBV-3067, ABBV-2222, F508del Mutation
Eligibility Criteria
Inclusion Criteria:
- Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation
- Stable pulmonary status
- Lung function >= 40 and <= 90% of predicted normal for age, gender and height at Screening
Exclusion Criteria:
- History of solid organ or hematopoietic transplant
- Cirrhosis with portal hypertension
- Use of CFTR modulator therapy within 60 days prior to Screening
Sites / Locations
- University of Arkansas /ID# 212541
- Tampa General Hospital /ID# 212342
- University of Iowa Hospitals and Clinics /ID# 212351
- Univ Michigan Med Ctr /ID# 212657
- Cardinal Glennon Children's Hospital /ID# 212349
- Washington University-School of Medicine /ID# 212352
- Nationwide Children's Hospital /ID# 213158
- Medical University of South Carolina /ID# 212187
- Vanderbilt University Medical Center /ID# 212353
- University of Utah /ID# 212350
- Uza /Id# 213412
- Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413
- UZ Brussel /ID# 212812
- UZ Gent /ID# 213411
- Universitair Ziekenhuis Leuven /ID# 213050
- University of Calgary /ID# 212555
- St. Paul's Hospital /ID# 212554
- QEII - Health Sciences Centre /ID# 212656
- Unity Health Toronto - St. Michael's Hospital /ID# 212552
- CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815
- McGill University Health Center Research Institute /ID# 212553
- Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655
- Fakultni Nemocnice Brno /ID# 213437
- Fakultni Nemocnice v Motole /ID# 212966
- Chu de Nice-Hopital L'Archet Ii /Id# 212862
- HCL - Hopital Lyon Sud /ID# 212899
- CHU Bordeaux - Hopital Haut Leveque /ID# 212898
- CHU Montpellier - Hôpital Saint Eloi /ID# 212856
- AP-HP - Hopital Cochin /ID# 212864
- CHU de Reims - Hôpital Maison Blanche /ID# 212910
- Fondation ILDYS /ID# 212857
- CHU Nantes - Hopital Laennec /ID# 212897
- Orszagos Koranyi Pulmonologiai Intezet /ID# 213494
- HagaZiekenhuis /ID# 212926
- Universitair Medisch Centrum Utrecht /ID# 212935
- Greenlane Clinical Centre /ID# 221103
- Christchurch Hospital /ID# 221105
- Waikato Hospital /ID# 221102
- Dunedin Hospital /ID# 221104
- Szpital Dzieciecy Polanki /ID# 221330
- Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 212820
- Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146
- Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596
- Barts Health NHS Trust /ID# 213016
- Nottingham University Hospitals NHS Trust /ID# 212531
- Cardiff & Vale University Health Board /ID# 212504
- Royal Papworth Hospital NHS Foundation Trust /ID# 212507
- Leeds Teaching Hospitals NHS Trust /ID# 212491
- Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291
- Royal Brompton and Harefield Hospitals /ID# 212490
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ABBV-3067 50 mg + Placebo for ABBV-2222
ABBV-3067 150 mg + Placebo for ABBV-2222
ABBV-3067 150 mg + ABBV-2222 10 mg
ABBV-3067 150 mg + ABBV-2222 30 mg
ABBV-3067 150 mg + ABBV-2222 100 mg
ABBV-3067 150 mg + ABBV-2222 200 mg
ABBV-3067 150 mg + ABBV-2222 300 mg
Placebo for ABBV-3067 + Placebo for ABBV-2222
Arm Description
Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Outcomes
Primary Outcome Measures
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
Secondary Outcome Measures
Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for analyses.
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03969888
Brief Title
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Official Title
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
June 9, 2022 (Actual)
Study Completion Date
June 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, ABBV-3067, ABBV-2222, F508del Mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABBV-3067 50 mg + Placebo for ABBV-2222
Arm Type
Experimental
Arm Description
Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Arm Title
ABBV-3067 150 mg + Placebo for ABBV-2222
Arm Type
Experimental
Arm Description
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Arm Title
ABBV-3067 150 mg + ABBV-2222 10 mg
Arm Type
Experimental
Arm Description
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
Arm Title
ABBV-3067 150 mg + ABBV-2222 30 mg
Arm Type
Experimental
Arm Description
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
Arm Title
ABBV-3067 150 mg + ABBV-2222 100 mg
Arm Type
Experimental
Arm Description
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
Arm Title
ABBV-3067 150 mg + ABBV-2222 200 mg
Arm Type
Experimental
Arm Description
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
Arm Title
ABBV-3067 150 mg + ABBV-2222 300 mg
Arm Type
Experimental
Arm Description
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
Arm Title
Placebo for ABBV-3067 + Placebo for ABBV-2222
Arm Type
Placebo Comparator
Arm Description
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
Intervention Type
Drug
Intervention Name(s)
ABBV-3067
Intervention Description
Tablet taken orally.
Intervention Type
Drug
Intervention Name(s)
Placebo ABBV-3067
Intervention Description
Tablet taken orally.
Intervention Type
Drug
Intervention Name(s)
ABBV-2222
Intervention Description
Capsule taken orally.
Intervention Type
Drug
Intervention Name(s)
Placebo ABBV-2222
Intervention Description
Capsule taken orally.
Primary Outcome Measure Information:
Title
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Description
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
Time Frame
Day 1 (Baseline) through Day 29
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
Description
Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
Time Frame
Day 1 (Baseline) through Day 29
Title
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
Description
FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Time Frame
Day 1 (Baseline) through Day 29
Title
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
Description
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Time Frame
Day 1 (Baseline) through Day 29
Title
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Description
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for analyses.
Time Frame
Day 1 (Baseline) through Day 29
Title
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
Description
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Time Frame
Day 1 (Baseline) through Day 29
Title
Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
Description
FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Time Frame
Day 1 (Baseline) through Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation
Stable pulmonary status
Lung function >= 40 and <= 90% of predicted normal for age, gender and height at Screening
Exclusion Criteria:
History of solid organ or hematopoietic transplant
Cirrhosis with portal hypertension
Use of CFTR modulator therapy within 60 days prior to Screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas /ID# 212541
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Tampa General Hospital /ID# 212342
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of Iowa Hospitals and Clinics /ID# 212351
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Univ Michigan Med Ctr /ID# 212657
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Cardinal Glennon Children's Hospital /ID# 212349
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University-School of Medicine /ID# 212352
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nationwide Children's Hospital /ID# 213158
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2664
Country
United States
Facility Name
Medical University of South Carolina /ID# 212187
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 212353
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Utah /ID# 212350
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
Uza /Id# 213412
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Brussel /ID# 212812
City
Jette
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Gent /ID# 213411
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 213050
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of Calgary /ID# 212555
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
St. Paul's Hospital /ID# 212554
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
QEII - Health Sciences Centre /ID# 212656
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Unity Health Toronto - St. Michael's Hospital /ID# 212552
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
McGill University Health Center Research Institute /ID# 212553
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Fakultni Nemocnice Brno /ID# 213437
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni Nemocnice v Motole /ID# 212966
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 212862
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
HCL - Hopital Lyon Sud /ID# 212899
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 212898
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi /ID# 212856
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
AP-HP - Hopital Cochin /ID# 212864
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU de Reims - Hôpital Maison Blanche /ID# 212910
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Fondation ILDYS /ID# 212857
City
Roscoff
ZIP/Postal Code
29684
Country
France
Facility Name
CHU Nantes - Hopital Laennec /ID# 212897
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Orszagos Koranyi Pulmonologiai Intezet /ID# 213494
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
HagaZiekenhuis /ID# 212926
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 212935
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Greenlane Clinical Centre /ID# 221103
City
Epsom
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Christchurch Hospital /ID# 221105
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waikato Hospital /ID# 221102
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Dunedin Hospital /ID# 221104
City
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Szpital Dzieciecy Polanki /ID# 221330
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-308
Country
Poland
Facility Name
Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 212820
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146
City
Bratislava
ZIP/Postal Code
821 01
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596
City
Bratislava
ZIP/Postal Code
821 06
Country
Slovakia
Facility Name
Barts Health NHS Trust /ID# 213016
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust /ID# 212531
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Cardiff & Vale University Health Board /ID# 212504
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Royal Papworth Hospital NHS Foundation Trust /ID# 212507
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust /ID# 212491
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Royal Brompton and Harefield Hospitals /ID# 212490
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
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