Clinical TrialID 4885
Treatment of TK2 Deficiency With Thymidine and Deoxycytidine
NCT03639701
Mitochondrial DNA Depletion Syndrome 2 Myopathic Type|Thymidine Kinase 2 Deficiency
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 4885
- Evidence Id
- 4885
- Core Evidence Id
- 4885
- Source Clinical Trial Id
- 4862
- Herb2 Clinical Trial Id
- HBCT004862
- Nct Id
- NCT03639701
- Title
- Treatment of TK2 Deficiency With Thymidine and Deoxycytidine
- Status
- Active_Not_Recruiting
- Phase
- Phase 1|Phase 2
- Study Result
- No
- Study Condition
- Mitochondrial DNA Depletion Syndrome 2 Myopathic Type|Thymidine Kinase 2 Deficiency
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Thymidine
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult, Older_Adult
- Enrollment
- 23
- Outcome Measure
- Alanine aminotransferase, Number of participants with treatment-related elevated alanine aminotransferase (ALT) serum level relative to upper limit of normal (expressed as ratios) grade 3 or higher as defined by CTCAE 4.03., Up to 60 months|Aspartate aminotransferase, Number of participants with treatment-related elevated aspartate aminotransferase (AST) serum level relative to upper limit of normal (expressed as ratios) grade 3 or higher as defined by CTCAE 4.03., Up to 60 months|Gamma-glutamyltransferase, Number of participants with treatment-related elevated gamma-glutamyltransferase (GGT) serum level relative to upper limit of normal (expressed as ratios) grade 3 or higher as defined by CTCAE 4.03., Up to 60 months|Blood lymphocyte count, Blood lymphocyte count increased relative to upper limit or normal or decreased relative to lower limit of normal (expressed as ratios) grade 3 or higher as defined by CTCAE 4.03., Up to 60 months|Creatinine, Serum creatinine level increased relative to upper limit of normal (expressed as ratios) grade 3 or higher as defined by CTCAE 4.03., Up to 60 months|Electrocardiogram, Number of patients with treatment related electrocardiogram (ECG) QT corrected interval (QTc) grade 3 or higher as defined by CTCAE version 4.03., Up to 60 months|Diarrhea, Patient-Reported Outcome Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Diarrhea 6a score (score range 0-30 with higher scores indicating more severe diarrhea), Up to 60 months
- Sponsor Collaborator
- Columbia University|Muscular Dystrophy Association|Hospital Universitario 12 de Octubre|Instituto de Salud Carlos III|University of Seville|Medical Research Council Mitochondrial Biology Unit|Centro de Investigación Biomédica en Red Enfermedades Raras (CIBERER), Spain|Hospitales Universitarios Virgen del Rocío|Universitat Autonoma de Barcelona
- Funded By
- OTHER
- Location
- Columbia University Irving Medical Center, New York, New York, 10032, United States
- Other Id
- AAAQ7552
- Start Date
- 2017-05-16
- Primary Completion Date
- 2025-04
- Completion Date
- 2025-04
- First Posted
- 2018-08-21
- Results First Posted
- Last Update Posted
- 2024-01-22
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT03639701
- Title Cn
- Title En
- Treatment of TK2 Deficiency With Thymidine and Deoxycytidine
- Bilingual Status
- semi_complete