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A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037489
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medivir

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Intervention Drug: MIV-711
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B
Hide Arm/Group Description Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 (NCT02705625) and whose symptoms did not clinically significantly deteriorate as defined by an increase in the Numeric Rating Scale (NRS) of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. Study Group B was recruited from patients receiving placebo in Study MIV-711-201 (NCT02705625) having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks.
Period Title: Overall Study
Started 46 4
Completed 39 4
Not Completed 7 0
Reason Not Completed
Adverse Event             4             0
Withdrawal by Subject             3             0
Arm/Group Title Group A Group B Total
Hide Arm/Group Description Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 46 4 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 4 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  65.2%
2
  50.0%
32
  64.0%
>=65 years
16
  34.8%
2
  50.0%
18
  36.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 4 participants 50 participants
61.5  (7.52) 65.5  (5.51) 61.8  (7.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 4 participants 50 participants
Female
31
  67.4%
3
  75.0%
34
  68.0%
Male
15
  32.6%
1
  25.0%
16
  32.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 4 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
46
 100.0%
4
 100.0%
50
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 4 participants 50 participants
Moldova 21 3 24
Georgia 3 0 3
Bulgaria 9 0 9
Germany 13 1 14
1.Primary Outcome
Title Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
Hide Description
  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)
  2. Number of Participants with Serious Adverse Events (SAEs)
  3. Number of Participants with TEAEs related to treatment
  4. Number of Participants with mild TEAEs
  5. Number of Participants with moderate TEAEs
  6. Number of Participants with severe TEAEs
  7. Number of Participants with TEAEs leading to early discontinuation
Time Frame Group A: 0-56 weeks; Group B: 0-30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:
Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks.
Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks.
Overall Number of Participants Analyzed 46 4
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
21
  45.7%
2
  50.0%
SAEs
2
   4.3%
0
   0.0%
Related TEAEs
1
   2.2%
0
   0.0%
Mild TEAEs
6
  13.0%
1
  25.0%
Moderate TEAEs
14
  30.4%
1
  25.0%
Severe TEAEs
1
   2.2%
0
   0.0%
TEAEs leading to early discontinuation
4
   8.7%
0
   0.0%
Time Frame Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment), up to 56 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B
Hide Arm/Group Description Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks.
All-Cause Mortality
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/46 (4.35%)      0/4 (0.00%)    
Cardiac disorders     
Angina pectoris  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Atrial fibrillation  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Cardiac failure  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Ischaemic cardiomyopathy  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Gastrointestinal disorders     
Duodenitis  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Gastritis  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchiectasis  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Bronchitis chronic  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Interstitial lung disease  1  1/46 (2.17%)  1 0/4 (0.00%)  0
Respiratory failure  1  1/46 (2.17%)  1 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/46 (28.26%)      2/4 (50.00%)    
Gastrointestinal disorders     
Chronic gastritis  1  2/46 (4.35%)  2 0/4 (0.00%)  0
Duodenal ulcer  1  2/46 (4.35%)  2 0/4 (0.00%)  0
Infections and infestations     
Nasopharyngitis  1  4/46 (8.70%)  4 1/4 (25.00%)  1
Upper respiratory tract infection  1  2/46 (4.35%)  2 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint swelling  1  2/46 (4.35%)  2 0/4 (0.00%)  0
Nervous system disorders     
Headache  1  1/46 (2.17%)  1 1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Linda Basse, Cheif Medical Officer
Organization: Medivir AB
Phone: +46 8 546 831 00
EMail: linda.basse@medivir.com
Layout table for additonal information
Responsible Party: Medivir
ClinicalTrials.gov Identifier: NCT03037489    
Other Study ID Numbers: MIV-711-202
First Submitted: December 22, 2016
First Posted: January 31, 2017
Results First Submitted: November 26, 2018
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019