A Phase 2 interventional study of Oral administration of 100 mg KH176 twice daily in Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation and Maternally Inherited Diabetes and Deafness (MIDD), sponsored by Khondrion BV. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Khondrion BV · Phase 2, Interventional, and Treatment
This is an open-label, multi-centre study in subjects with a genetically confirmed mitochondrial deoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation who completed study KH176-202. In the KH176-203 study subjects will be receiving KH176 100 mg BID or KH176 50 mg bid in die (BID) (as determined by the investigator based on safety / tolerability considerations) for a year, thereby ensuring continued treatment with KH176 after study KH176-202. A final follow-up visit is scheduled 4 weeks after the intake of the last dose of study medication for patients not rolling over into the compassionate use program. Primary safety data and secondary efficacy (endpoint) data will be monitored and reviewed every three months by an independent Data Safety Monitoring Board (DSMB) to evaluate potential risks and benefits.
Mitochondrial diseases, estimated prevalence 1 in 4,300 adults, are caused by pathogenic mutations in genes that ultimately encode mitochondrial proteins of the different enzyme complexes of the oxidative phosphorylation system (OXPHOS). Of these mutations, the 3243> G nucleotide change in the mitochondrially encoded transfer RNALeu (UUR) leucine 1 gene (MT TL 1) is the most prevalent one. When mitochondria are defective, it can result in a wide variety of serious and debilitating diseases, especially in energy-demanding tissues such as the muscles and brain. Therefore, signs and symptoms of mitochondrial disease can include a variety of symptoms such as fatigue, exercise tolerance, muscle weakness, and ataxia, heart failure, deafness, blindness, stunted growth, and cognitive learning disabilities.
Despite advances in understanding mitochondrial disease, treatment options are extremely limited and largely supportive to date. Therefore, there is an urgent need for new treatments. KH176, a pharmaceutical ingredient (API), is an orally bioavailable small molecule under development for the treatment of these conditions. KH176 acts as a potent intracellular redox modulating agent targeting the reactive oxygen species as demonstrated in a number of in vitro and in vivo assays. An earlier phase II study showed positive effects of KH176 on alertness and mood.
The main objective of the current study is to enable continued treatment with KH176-202 for patients who have completed the KH176-202 study. Since KH176 is expected to be a chronic treatment for mitochondrial diseases, this study will examine long-term safety and explore long-term efficacy. To this end, the highest dose of 100 mg KH176 twice daily (safe and well tolerated by the target group in study KH176-201) will be used as the initial dose, to be administered over 1 year (minimum 365 days). Study KH176-202 uses doses of 50 mg twice daily and 100 mg twice daily. Currently, this study is still blinded, but a review of blinded safety data suggests that these doses are well tolerated.
Primary safety data and secondary efficacy (endpoint) data will be monitored and reviewed every three months by an independent Data Safety Monitoring Board (DSMB) to evaluate potential risks and benefits.
37 studies on the registry are indexed under MELAS Syndrome; 8 are open to participants now.
This study's enrollment of 11 is below the median of 24 across 29 interventional studies indexed under MELAS Syndrome.
Browse MELAS Syndrome studies →Khondrion BV is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Compared within MELAS Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mitochondrial Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women of must be willing to use highly effective methods during the entire study, i.e., combined (estrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with inhibition of ovulation;, oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; use of an intrauterine device; an intrauterine hormone releasing system, bilateral tubal occlusion and vasectomy of the partner. Any hormonal contraception method must be supplemented with a barrier method (preferably male condom). Vasectomised partner is considered a highly effective birth control method provided that partner is the sole sexual partner of the subject and that the vasectomised partner has received medical assessment of the surgical success. Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. Reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Note 1: Natural family planning methods, female condom, cervical cap or diaphragm are not considered adequate contraceptive methods in the context of this study.
Note 2: To be considered not of childbearing potential, potential female subjects must be for at least two years, or have been surgically sterilised (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) for at least 6 months prior to Screening.
Note 3: KH176 has been shown non-genotoxic judged from the Ames test, Chromosomal Aberration test and in vivo Micronucleus test. Moreover, appreciable systemic exposure from the exposure to (\~2.5 mL) semen is extremely unlikely. However, until reproductive toxicology studies have confirmed that KH176 does not adversely affect normal reproduction in adult males and females, as well as causing developmental toxicity in the offspring, the following contraceptive precautions must be adhered to:
Exclusion criteria:
In order to be eligible to participate in this study, a subject must not meet any of the following criteria:
abnormal laboratory, vital signs or physical or mental health; e) (ASAT) or alanine aminotransferase (ALAT) > 3 x (ULN), or > 3 x ULN at screening. If a patient has ASAT or ALAT > 3 x ULN but \< 3.5 x ULN, re-assessment is allowed at the investigator's discretion.
f) Estimated ≤ 60 mL/min according to the CKD-EPI formula at screening.
g) Systolic blood pressure > 150 mmHg at screening or baseline. h) All other clinically relevant parameters at screening or baseline as judged by the Investigator.
The use of any of the following medication and/or supplements within 4 weeks or 5 times the half-life (whichever is longer) prior to the first dosing of the study medication:
any medication negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, anti-virals, amiodarone, and non-steroidal anti-inflammatory drugs (NSAIDs)), unless stable for at least one month before first dosing and remaining stable throughout the study.
Note: thus, mitoQ and any medication negatively influencing mitochondrial functioning are allowed as long as the dose has been stable for at least one month prior to first dosing and remains stable throughout the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral administration of 100 mg KH176 twice daily
Drug: Oral administration of 100 mg KH176 twice daily
Drug: KH176
Treatment Emergent Adverse Events (TEAE)
Frequency of TEAEs throughout the treatment period.
Time frame: 52 weeks
Blood Pressure (mmHG)
Changes from baseline to each assessment visit in blood pressure (mmHG)
Time frame: 52 weeks
Safety Outcomes
Changes from baseline to each assessment visit in vital signs, laboratory parameters (chemistry, haematology, urinalysis).
Time frame: 52 weeks
Cognitive functioning: Attention
The attention domain score of cognitive functioning, as assessed by the Identification Test of the Cogstate computerised cognitive testing battery.
Time frame: 52 weeks
Executive functioning
The executive functioning domain score of cognitive functioning, as assessed by the Groton Maze Learning Test of the Cogstate computerised cognitive testing battery.
Time frame: 52 weeks
Psychomotor functioning
The psychomotor functioning domain score of cognitive functioning, as assessed by the Detection Test of the Cogstate computerised cognitive testing battery.
Time frame: 52 weeks
Visual learning
The visual learning domain score of cognitive functioning, as assessed by the One Card Learning Test of the Cogstate computerised cognitive testing battery.
Time frame: 52 weeks
Working Memory
The working memory domain score of cognitive functioning, as assessed by the One Back Test of the Cogstate computerised cognitive testing battery.
Time frame: 52 weeks
Verbal learning
The verbal learning functioning domain score of cognitive functioning, as assessed by the International Shopping List Test of the Cogstate computerised cognitive testing battery.
Time frame: 52 weeks
Test of Attentional Performance (TAP)
Standardised test to evaluate alertness and mental flexibility.
Time frame: 52 weeks
Beck Depression Inventory (BDI)
21-question multiple-choice self-report inventory, for measuring the severity of depression.
Time frame: 52 weeks
Hamilton Anxiety and Depression Score (HADS)
Subject-reported outcome measure and comprises 14 items equally divided over the two subscales anxiety (HADS-A) and depression (HADS-D).
Time frame: 52 weeks
Newcastle Mitochondrial Disease Scale for Adults (NMDAS)
Semi-quantitative clinical rating scale designed for mitochondrial disease. The rating scale explores several domains: current function, system specific involvement, current clinical assessment and quality of life.
Time frame: 52 weeks
Number of headache days
Self report diary.
Time frame: 52 weeks
Pure Tone Audiometry (PTA)
Standardized test to measure individual hearing threshold levels.
Time frame: 52 weeks
University of Penn Smell Identification Test (UPSIT)
Test to measure the individual's ability to detect odors at a suprathreshold level.
Time frame: 52 weeks
Cognitive Failure Questionnaire (CFQ)
Questionnaire to evaluate subjective cognitive functioning.
Time frame: 52 weeks
Neuro-QoL Fatigue Short Form (quality in life in neurological disorders)
8-item self assessment questionnaire evaluating the perception of fatigue and its impact in daily life activities.
Time frame: 52 weeks
Five Times Sit to stand test (5XSST)
Test to measure lower limb functional strength.
Time frame: 52 weeks
Handgrip strength
Test to measure upper extremity deficits.
Time frame: 52 weeks
HbA1c
Glucose homeostasis / diabetes control.
Time frame: 52 weeks
Mean daily insulin dose
Glucose homeostasis / diabetes control.
Time frame: 52 weeks
Mean daily oral antidiabetics dose
Glucose homeostasis / diabetes control.
Time frame: 52 weeks
Short Form-36 (SF-36)
36-item self report health related quality of life questionnaire evaluating of functional health and well-being, physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health.
Time frame: 52 weeks
EQ-5Dimension-5Level (EQ-5D-5L)
Self-report health-related quality of life (HRQoL) instrument evaluating mobility, self-care, usual activities, pain/discomfort, anxiety/depression and perceived health.
Time frame: 52 weeks
Speech audiometry: Matrix test
Standardized test to measure individual hearing thresholds levels.
Time frame: 52 weeks
Short Form McGill Pain Questionnaire (SF-MPQ)
Self-rating questionnaire assessing severity, affective, and evaluative dimensions of subjective pain experience using a sensory and affective subscales and a visual analogue scale (VAS) to record the patient's present pain intensity.
Time frame: 52 weeks
Electrocardiogram (ECG): PQ interval (milliseconds)
Changes from baseline to each assessment visit in PQ interval
Time frame: 52 weeks
Electrocardiogram (ECG): QRS duration (milliseconds) and morphology (peak, axis)
Changes from baseline to each assessment visit in QRS duration (milliseconds) and morphology (peak, axis)
Time frame: 52 weeks
Electrocardiogram (ECG): QTc
Changes from baseline to each assessment visit in QTc
Time frame: 52 weeks
Electrocardiogram (ECG): T peak - T end interval
Changes from baseline to each assessment visit in T peak - T end interval
Time frame: 52 weeks
Electrocardiogram (ECG): T wave morphology: peak, symmetry
Changes from baseline to each assessment visit in T wave morphology: peak, symmetry
Time frame: 52 weeks
Haematology: haemoglobin (Hb)
Changes from baseline to each assessment visit in haemoglobin (Hb)
Time frame: 52 weeks
Haematology: haematocrit (Ht)
Changes from baseline to each assessment visit in haematocrit (Ht)
Time frame: 52 weeks
Haematology: mean corpuscular haemoglobin (MCH)
Changes from baseline to each assessment visit in mean corpuscular haemoglobin (MCH)
Time frame: 52 weeks
Haematology: mean corpuscular haemoglobin concentration (MCHC)
Changes from baseline to each assessment visit in mean corpuscular haemoglobin concentration (MCHC)
Time frame: 52 weeks
Haematology: red blood cell count (RBC)
Changes from baseline to each assessment visit in red blood cell count (RBC)
Time frame: 52 weeks
Haematology: mean corpuscular volume (MCV)
Changes from baseline to each assessment visit in mean corpuscular volume (MCV)
Time frame: 52 weeks
Haematology: white blood cell (WBC) count
Changes from baseline to each assessment visit in white blood cell (WBC) count
Time frame: 52 weeks
Haematology: white blood cell differential (WBC differential: neutrophils, lymphocytes, monocytes, eosinophils, basophils)
Changes from baseline to each assessment visit in WBC differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils)
Time frame: 52 weeks
Haematology: thrombocytes
Changes from baseline to each assessment visit in thrombocytes
Time frame: 52 weeks
Chemistry: total protein
Changes from baseline to each assessment visit in total protein
Time frame: 52 weeks
Chemistry: alkaline phosphatase
Changes from baseline to each assessment visit in alkaline phosphatase
Time frame: 52 weeks
Chemistry: aspartate aminotransferase (ASAT)
Changes from baseline to each assessment visit in aspartate aminotransferase (ASAT)
Time frame: 52 weeks
Chemistry: alanine aminotransferase (ALAT)
Changes from baseline to each assessment visit in alanine aminotransferase (ALAT)
Time frame: 52 weeks
Chemistry: gamma-glutamyl transferase (gamma-GT)
Changes from baseline to each assessment visit in gamma-glutamyl transferase (gamma-GT)
Time frame: 52 weeks
Chemistry: total bilirubin
Changes from baseline to each assessment visit in total bilirubin
Time frame: 52 weeks
Chemistry: urea
Changes from baseline to each assessment visit in urea
Time frame: 52 weeks
Chemistry: creatinine
Changes from baseline to each assessment visit in creatinine
Time frame: 52 weeks
Chemistry: creatinine kinase
Changes from baseline to each assessment visit in creatinine kinase
Time frame: 52 weeks
Chemistry: sodium
Changes from baseline to each assessment visit in sodium
Time frame: 52 weeks
Chemistry: potassium
Changes from baseline to each assessment visit in potassium
Time frame: 52 weeks
Chemistry: calcium
Changes from baseline to each assessment visit in calcium
Time frame: 52 weeks
Chemistry: chloride
Changes from baseline to each assessment visit in chloride
Time frame: 52 weeks
Chemistry: lactate
Changes from baseline to each assessment visit in lactate
Time frame: 52 weeks
Chemistry: amylase
Changes from baseline to each assessment visit in amylase
Time frame: 52 weeks
Chemistry: lipase
Changes from baseline to each assessment visit in lipase
Time frame: 52 weeks
Chemistry: uric acid
Changes from baseline to each assessment visit in uric acid
Time frame: 52 weeks
Chemistry: phosphate
Changes from baseline to each assessment visit in phosphate
Time frame: 52 weeks
Chemistry: human serum albumin
Changes from baseline to each assessment visit in human serum albumin
Time frame: 52 weeks
Chemistry: glucose
Changes from baseline to each assessment visit in glucose
Time frame: 52 weeks
Chemistry: HbA1c
Changes from baseline to each assessment visit in HbA1c
Time frame: 52 weeks
Chemistry: thyroid-stimulating hormone (TSH)
Changes from baseline to each assessment visit in thyroid-stimulating hormone (TSH)
Time frame: 52 weeks
Chemistry: free thyroxine (fT4)
Changes from baseline to each assessment visit in free thyroxine (fT4)
Time frame: 52 weeks
Chemistry: C-reactive protein (CRP)
Changes from baseline to each assessment visit in C-reactive protein (CRP)
Time frame: 52 weeks
Chemistry: Lipids: cholesterol, triglycerides, low density lipoproteins (LDL), high density lipoproteins (HDL)
Changes from baseline to each assessment visit in Lipids: cholesterol, triglycerides, low density lipoproteins (LDL), high density lipoproteins (HDL)
Time frame: 52 weeks
Heart rate (bpm)
Changes from baseline to each assessment visit in heart rate (bpm)
Time frame: 52 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in Jun 2023, 21 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Khondrion BV