A Phase 2 interventional study of MIV-711 in Osteoarthritis, Knee, sponsored by Medivir. Completed at 4 sites in 4 countries. Open to participants aged 40 Years to 81 Years. Per ClinicalTrials.gov, last updated 2019-03-18.
Sponsored by Medivir · Phase 2, Interventional, and Treatment
This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Medivir is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MIV-711 for a total of 26 weeks
Drug: MIV-711
MIV-711 administered orally once daily
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
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
| Milestone | Group A | Group B |
|---|---|---|
| Started | 46 | 4 |
| Completed | 39 | 4 |
| Not completed | 7 | 0 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
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
| Participants | Group A | Group B |
|---|---|---|
| TEAEs | 21 | 2 |
| SAEs | 2 | 0 |
| Related TEAEs | 1 | 0 |
| Mild TEAEs | 6 | 1 |
| Moderate TEAEs | 14 | 1 |
| Severe TEAEs | 1 | 0 |
| TEAEs leading to early discontinuation | 4 | 0 |
Collected over 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.. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A | 0/46 (0%) | 2/46 (4.3%) | 13/46 (28.3%) |
| Group B | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | Group A | Group B |
|---|---|---|
| Angina pectorisCardiac disorders | 1/46 | 0/4 |
| Atrial fibrillationCardiac disorders | 1/46 | 0/4 |
| Cardiac failureCardiac disorders | 1/46 | 0/4 |
| Ischaemic cardiomyopathyCardiac disorders | 1/46 | 0/4 |
| BronchiectasisRespiratory, thoracic and mediastinal disorders | 1/46 | 0/4 |
| Bronchitis chronicRespiratory, thoracic and mediastinal disorders | 1/46 | 0/4 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 1/46 | 0/4 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/46 | 0/4 |
| DuodenitisGastrointestinal disorders | 1/46 | 0/4 |
| GastritisGastrointestinal disorders | 1/46 | 0/4 |
| Event | Group A | Group B |
|---|---|---|
| HeadacheNervous system disorders | 1/46 | 1/4 |
| NasopharyngitisInfections and infestations | 4/46 | 1/4 |
| Chronic gastritisGastrointestinal disorders | 2/46 | 0/4 |
| Duodenal ulcerGastrointestinal disorders | 2/46 | 0/4 |
| Joint swellingMusculoskeletal and connective tissue disorders | 2/46 | 0/4 |
| Upper respiratory tract infectionInfections and infestations | 2/46 | 0/4 |
| Age, Categorical(Participants) | Group A | Group B | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 2 | 32 |
| >=65 years | 16 | 2 | 18 |
| Age, Continuous(years) | Group A | Group B | Total |
|---|---|---|---|
| Mean | 61.5 ± 7.52 | 65.5 ± 5.51 | 61.8 ± 7.42 |
| Sex: Female, Male(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Female | 31 | 3 | 34 |
| Male | 15 | 1 | 16 |
| Race (NIH/OMB)(Participants) | Group A | Group B | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 46 | 4 | 50 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Group A | Group B | Total |
|---|---|---|---|
| Moldova | 21 | 3 | 24 |
| Georgia | 3 | 0 | 3 |
| Bulgaria | 9 | 0 | 9 |
| Germany | 13 | 1 | 14 |
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