TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03251963
Drug: Variable Dose Enoxaparin
Normalized name: enoxaparin
DrugBank: Enoxaparin (DB01225)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Eligible patients will be administered 0.5 mg/kg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
Study: NCT00425334
Drug: Hemospan (MP4OX)
Normalized name: Aerospan
DrugBank: MP4 (DB05313)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 250 mL or 500 mL Hemospan (MP4OX)
Study: NCT00173875
Drug: Iressa
Normalized name: Iressa
DrugBank: Gefitinib (DB00317)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02044796
Drug: Cladribine
Normalized name: Cladribine
DrugBank: Cladribine (DB00242)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT02044796
Drug: Cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT02044796
Drug: Mitoxantrone Hydrochloride
Normalized name: Mitoxantrone Hydrochloride
DrugBank: Mitoxantrone (DB01204)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT01284296
Drug: Lidocaine digital block
Normalized name: Ivy Block
DrugBank: Lidocaine (DB00281)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: One dose of lidocaine 2% injected locally into one finger (2 mls total)
Study: NCT03055663
Drug: Midazolam
Normalized name: Midazolam
DrugBank: Midazolam (DB00683)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)
Study: NCT00124995
Drug: terbutaline
Normalized name: Terbutaline
DrugBank: Terbutaline (DB00871)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01216696
Drug: ipilimumab
Normalized name: Ipilimumab
DrugBank: Ipilimumab (DB06186)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression, toxicities requiring discontinuation , withdrawal of consent,pregnancy, death or lost to follow up whichever occurs first.
Study: NCT01344174
Drug: 5 days dexamethasone therapy
Normalized name: dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: dexamethasone 10mg, intravenously, po daily for the first 5 days
Study: NCT03939884
Drug: MuscleCare Topical Product
Normalized name: camphor
DrugBank: Camphor (DB01744)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
Study: NCT03709823
Drug: Cytisine
Normalized name: Cytisine
DrugBank: Cytisine (DB09028)
Approvals — FDA: no, EMA: no, PMDA: no
Description: film coated tablet containing 1.5 mg cytisine in a single tablet
Study: NCT01194336
Drug: Huperzine A
Normalized name: Huperzine A
DrugBank: Huperzine A (DB04864)
Approvals — FDA: no, EMA: no, PMDA: no
Description: dosage form: tablet dose frequency: once only
Study: NCT01194336
Drug: Donepezil
Normalized name: Donepezil
DrugBank: Donepezil (DB00843)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: dosage form: tablet dosage frequency: once only
Study: NCT01194336
Drug: Galantamine
Normalized name: Galantamine
DrugBank: Galantamine (DB00674)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: dosage form: tablet dosage frequency: once only
Study: NCT02960919
Drug: parenteral ampicillin/ penicillin
DrugBank: Ampicillin (DB00415)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00283790
Drug: zolpidem tartrate
Normalized name: Zolpidem Tartrate
DrugBank: Zolpidem (DB00425)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01466452
Drug: Aspirin
Normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: single-dose aspirin in 100 mg 1 tablet every 24 hours
Study: NCT01466452
Drug: Aspirin
Normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: single-dose aspirin 200 mg 1 tablet every 24 hours
Study: NCT01466452
Drug: Aspirin
Normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: double-dose aspirin 100 mg 1 tablet every 12 hours
Study: NCT04163978
Drug: Budesonide
Normalized name: Budesonide
DrugBank: Budesonide (DB01222)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Saline based sinus irrigation 1mg Budesinide solution
Study: NCT01797601
Drug: Human Insulin
Normalized name: Human insulin
DrugBank: Insulin human (DB00030)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 160 U of insulin
Study: NCT00380614
Drug: Lamivudine
Normalized name: Lamivudine
DrugBank: Lamivudine (DB00709)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT03732001
Drug: Anlotinib combined Docetaxel
Normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Anlotinib ( 12mg, QD, PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2, IV, d1, 21 days per cycle)
Study: NCT03732001
Drug: Docetaxel
Normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Docetaxel (75mg/m2, IV, d1, 21 days per cycle)
Study: NCT01269424
Drug: O6-benzylguanine
Normalized name: O6-benzylguanine
DrugBank: 6-O-benzylguanine (DB11919)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01269424
Drug: temozolomide
Normalized name: Temozolomide
DrugBank: Temozolomide (DB00853)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01361464
Drug: Tipifarnib
Normalized name: Tipifarnib
DrugBank: Tipifarnib (DB04960)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT03326609
Drug: Ropivacaine
Normalized name: Ropivacaine
DrugBank: Ropivacaine (DB00296)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h)
Study: NCT00894049
Drug: reduced intensity conditionings
Normalized name: Iron, reduced
DrugBank: Iron (DB01592)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)
Study: NCT02651727
Drug: Part B, Cohort 1- VS-4718, nab-paclitaxel, gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: IV treatment in 28-day cycles (nab-paclitaxel 125 mg/m2 over 30 minutes on Days 1, 8, and 15 and gemcitabine at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15) and oral VS 4718 BID continuously starting on Day 1 of Cycle 1
Study: NCT02651727
Drug: Part B, Cohort 2- VS4718, nab-paclitaxel, gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: IV treatment for the first 2 cycles, followed by IV treatment and oral VS-4718 BID continuously starting on Day 1 of Cycle 3
Study: NCT02651727
Drug: Part A- VS-4718, nab-paclitaxel, gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Part A- intravenous (IV) treatment in 28-day cycles (nab-paclitaxel 125 mg/m2 over 30 minutes on Days 1, 8, and 15 and gemcitabine at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15) and oral VS 4718 twice-daily (BID) continuously starting on Cycle 1 Day 2. The starting dose of VS-4718 will be 200 mg BID.
Study: NCT02467010
Drug: Bortezomib
Normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.~Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets \> 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause.
Study: NCT02467010
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.~Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets \> 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause.
Study: NCT01894451
Drug: 89Zr-bevacizumab
Normalized name: 89ZR-BEVACIZUMAB
DrugBank: Bevacizumab zirconium Zr-89 (DB14907)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 89Zr-bevacizumab is a newly developed radiotracer. Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance. The amount of the compound or drug in a radiotracer is also very small. Radiotracers are used to make images of processes that are happening in the body, but they do not affect how the body works. 89Zr-bevacizumab is made up of the drug bevacizumab and the radioactive substance zirconium-89 (89Zr). 89Zr-bevacizumab is used for an imaging procedure called positron emission tomography/computed tomography (PET/CT). 89Zr-bevacizumab-PET/CT will be performed in this study at baseline, after 2 cycles of preoperative chemotherapy and at the completion of chemotherapy.
Study: NCT00805753
Drug: ACTH
Normalized name: ACTH
DrugBank: Corticotropin (DB01285)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: comparison of different dosages of drug
Study: NCT00115687
Drug: 2 mg nicotine polacrilex
Normalized name: nicotine
DrugBank: Nicotine (DB00184)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT05983055
Drug: Dexamethasone 20mg
Normalized name: DEXAMETHASONE 20MG TAB
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Periarticular dexamethasone injection
Study: NCT00140621
Drug: Agalsidase beta
Normalized name: Agalsidase beta
DrugBank: Agalsidase beta (DB00103)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02845765
Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)
Normalized name: Fibrinolysis inhibitor
DrugBank: Aprotinin (DB06692)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT04492020
Drug: Ubrogepant 100 mg
Normalized name: ubrogepant 100 MG
DrugBank: Ubrogepant (DB15328)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Study: NCT00048204
Drug: paroxetine
Normalized name: Paroxetine
DrugBank: Paroxetine (DB00715)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02517437
Drug: Interscalene block
Normalized name: Ivy Block
DrugBank: Bentoquatam (DB00516)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: After sterile skin preparation with chlorhexidine and infiltration with 1 mL of 1% lidocaine, a 5 cm 22 G insulated needle is then inserted and local anesthetic solution (20 mL of 0.5% ropivacaine) will be injected in 5 mL aliquots after negative aspiration for blood to achieve spread posterior to or between the C5 and C6 nerve roots.
Study: NCT00327288
Drug: imexon
Normalized name: Imexon
DrugBank: Imexon (DB05003)
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV variable dosages, days 1-5 every 21 days for duration of study
Study: NCT00327288
Drug: docetaxel
Normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: IV once every 21 days for duration of study
Study: NCT02693093
Drug: NI-03
Normalized name: Toto ni vavalagi oil
DrugBank: Castor oil (DB11113)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03579966
Drug: Amifampridine Phosphate
Normalized name: Amifampridine Phosphate
DrugBank: Amifampridine (DB11640)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day
Study: NCT02620150
Drug: Escitalopram
Normalized name: Escitalopram
DrugBank: Escitalopram (DB01175)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 10 week trial
Study: NCT03468335
Drug: Irinotecan Liposomal Injection [Onivyde]
DrugBank: Irinotecan (DB00762)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cancer treatment for PDAC:~* Nal-IRI (4.3 mg/ml) 70 mg/m2 as 1.5 hour infusion~* 5-FU 2400 mg/m2 as 46 hour infusion~* Folinic acid 400 mg/m2 as 0.5 hour infusion~* all on D1 of each cycle; Cycle q2w ± 5 days~Treatment until progressive disease or intolerable toxicity or withdrawal of consent.
Study: NCT01713049
Drug: 18F-FLT
Normalized name: 18F-FLT
DrugBank: Alovudine F-18 (DB14930)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.07 mCi/kg of 18F-FDG will be injected intravenously. The data acquisition will be started at 90 minutes after the injection using 2-D acquisition from a GE DISCOVERY ST PET/CT scanner (GE Medical Systems, Milwaukee, WI).
Study: NCT00476554
Drug: Sapacitabine
Normalized name: Sapacitabine
DrugBank: Sapacitabine (DB06365)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sapacitabine
Study: NCT01584206
Drug: Ezetimibe
Normalized name: Ezetimibe
DrugBank: Ezetimibe (DB00973)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 10mg ezetimibe/day, at least 4 months
Study: NCT04258475
Drug: Raltegravir standard dosage of 1200 mg (two 600 mg tablets) orally once daily.
DrugBank: Raltegravir (DB06817)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Raltegravir will be dosed in a fasted state in all periods. Participants will take Raltegravir along with other ART medication.
Study: NCT00003875
Drug: busulfan
Normalized name: Busulfan
DrugBank: Busulfan (DB01008)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given PO or IV
Study: NCT00003875
Drug: etoposide
Normalized name: Etoposide
DrugBank: Etoposide (DB00773)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00649818
Drug: Lorazepam Tablets 2 mg
Normalized name: lorazepam Oral Tablet
DrugBank: Lorazepam (DB00186)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 2mg, single dose fasting
Study: NCT00616954
Drug: ATG-F
Normalized name: ATG-Fresenius S
DrugBank: ATG-Fresenius S (DB05320)
Approvals — FDA: no, EMA: no, PMDA: no
Description: ATG-f
Study: NCT04170855
Drug: Furosemide Injection
Normalized name: furosemide Injection
DrugBank: Furosemide (DB00695)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: We will measure kidney sodium content in patient with cardiorenal syndrome. we will inject within the week of this first measurement furosemide only in patient who will be resistant to diuretics (Based on these parameters, diuretic response will be defined as:~* A reduction in fractional spot urinary sodium~* An increase in urinary volume~* A \>1 kg reduction in body weight within 24 hours from diuretic administration (extrapolation of guidance on management of acute HF) and we will do another measurement of kidney sodium content after furosemide injection.
Study: NCT04580121
Drug: Tocilizumab
Normalized name: Tocilizumab
DrugBank: Tocilizumab (DB06273)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Tocilizumab will be administered as an IV infusion 8 mg/kg (for participants with a weight of 30 kg and above) and 12 mg/kg (for participants with a weight of less than 30 kg). Tocilizumab will be given as rescue medication.
Study: NCT04580121
Drug: Dasatinib
Normalized name: Dasatinib
DrugBank: Dasatinib (DB01254)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Dasatinib 100 mg film-coated tablets will be administered daily until symptom resolution (up to 100 mg twice daily \[BID\] for a maximum 3 days); orally. Dasatinib will be given as rescue medication.
Study: NCT04580121
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 20 mg IV of dexamethasone will be administered as pre-medication at least 60 minutes prior to the all RO7283420 infusions or injections during cycle 1.
Study: NCT04580121
Drug: Diphenhydramine
Normalized name: Diphenhydramine
DrugBank: Diphenhydramine (DB01075)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 25 mg or 50 mg of diphenhydramine will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection.
Study: NCT01169532
Drug: ridaforolimus
Normalized name: Ridaforolimus
DrugBank: Ridaforolimus (DB06233)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT01169532
Drug: vorinostat
Normalized name: Vorinostat
DrugBank: Vorinostat (DB02546)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given PO
Study: NCT02808949
Drug: Dapivirine
Normalized name: dapivirine
DrugBank: Dapivirine (DB08639)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to wear for approximately 14 continuous days. Participants age 18 and over, at least 6 weeks postpartum, able to produce and express breast milk for 14 consecutive days.
Study: NCT01708590
Drug: 210 mg brodalumab
Normalized name: brodalumab
DrugBank: Brodalumab (DB11776)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 210 mg brodalumab administered subcutaneous (SC)
Study: NCT01708590
Drug: 140 mg brodalumab
Normalized name: brodalumab 140 MG/ML
DrugBank: Brodalumab (DB11776)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 140 mg brodalumab administered subcutaneous (SC)
Study: NCT03708965
Drug: JR-141
Normalized name: IMMUNOGLOBULIN G1, ANTI-(HUMAN TRANSFERRIN RECEPTOR) (HUMAN-MUS MUSCULUS MONOCLONAL JR-141 .GAMMA.1-CHAIN) FUSION PROTEIN WITH PEPTIDE (SYNTHETIC 2-AMINO ACID LINKER) FUSION PROTEIN WITH HUMAN IDURONATE-2-SULFATASE, DISULFIDE WITH HUMAN-MUS MUSCULUS MONO
DrugBank: Pabinafusp alfa (DB15633)
Approvals — FDA: no, EMA: no, PMDA: yes
Description: IV infusion (lyophilized powder)
Study: NCT01805830
Drug: MP513
Normalized name: Methylphenidate
DrugBank: Methylphenidate (DB00422)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day
Study: NCT02068521
Drug: somavaratan
Normalized name: Somavaratan
DrugBank: Somavaratan (DB12421)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subcutaneous injection
Study: NCT00045175
Drug: 7-hydroxystaurosporine
Normalized name: 7-Hydroxystaurosporine
DrugBank: 7-Hydroxystaurosporine (DB01933)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00045175
Drug: topotecan hydrochloride
Normalized name: Topotecan Hydrochloride
DrugBank: Topotecan (DB01030)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00125411
Drug: satraplatin and docetaxel
Normalized name: satraplatin
DrugBank: Docetaxel (DB01248)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Satraplatin - oral administration within 2 hours of docetaxel infusion. Subsequent dosing will be on days 2-5 at approximate 24 hour intervals.~Docetaxel will be administered as intravenous infusion over 1 hour followed by saline flush.
Study: NCT01359644
Drug: PSI-7977
Normalized name: psi-Norephedrine
DrugBank: Cathine (DB01486)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablets, oral, 400 mg, once daily
Study: NCT01359644
Drug: Daclatasvir
Normalized name: Daclatasvir
DrugBank: Daclatasvir (DB09102)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Tablets, oral, 60 mg, once daily
Study: NCT01359644
Drug: Ribavirin
Normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Tablets, oral, 200 mg
Study: NCT00311311
Drug: tacrolimus
Normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
Study: NCT00311311
Drug: mycophenolate mofetil
Normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
Study: NCT00311311
Drug: prednisone
Normalized name: Prednisone
DrugBank: Prednisone (DB00635)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
Study: NCT00311311
Drug: sirolimus
Normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol.~On study Day 1 Conversion, the daily dose of TAC will not be taken, and SRL is initiated as a single 5-10 mg loading dose, followed by 3 mg/day on subsequent days, adjusted to maintain a SRL target trough level of 8-15 ng/mL through to month 24 post-transplant, then 5-12 ng/mL to the end of month 36 post-transplant.