AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT05228041
Drug: Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks)
Trial: NCT06064175
Drug: Ibuprofen 400 mg
RxNorm normalized name: ibuprofen 400 MG
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients will receive ibuprofen 400 mg/4 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl).
Trial: NCT06064175
Drug: Ibuprofen 800 mg
RxNorm normalized name: ibuprofen 800 MG
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients will receive ibuprofen 800 mg/8 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl).
Trial: NCT04341935
Drug: Insulin regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard of care insulin regimen as per hospital protocol
Trial: NCT04950504
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CNP-201 Placebo
Trial: NCT04325880
Drug: Placebo oral tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients in this arm will receive placebo oral tablet once daily
Trial: NCT05076227
Drug: IM injection of vaccination (mRNA vaccination)
RxNorm normalized name: smallpox vaccine live, New York City Board of Health vaccinia strain Injectable Solution [ACAM2000]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: mRNA vaccination
Trial: NCT05076227
Drug: IM injection of vaccination (vector based vaccination)
RxNorm normalized name: smallpox vaccine live, New York City Board of Health vaccinia strain Injectable Solution [ACAM2000]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: vector based vaccination
Trial: NCT06355193
Drug: Langenlianqiao
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The data of patients with COVID-19 mild disease treated in our Hospital from November to December 2022 were collected, and the patients were divided into 100 cases of langenlianqiao(LGLQ) treatment group, 100 cases of LianhuaQingWen(LHQW) treatment group, and 53 cases of placebo control group according to the treatments they received, and the proportion of occurrence of major clinical symptoms, the time of symptom disappearance, and the number of days in hospitalization, and the duration of infection were compared among the three groups.
Trial: NCT06425705
Drug: Silymarin
RxNorm normalized name: silymarin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors.
Trial: NCT06425705
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors.
Trial: NCT06355193
Drug: LianhuaQingWen
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The data of patients with COVID-19 mild disease treated in our Hospital from November to December 2022 were collected, and the patients were divided into 100 cases of langenlianqiao(LGLQ) treatment group, 100 cases of LianhuaQingWen(LHQW) treatment group, and 53 cases of placebo control group according to the treatments they received, and the proportion of occurrence of major clinical symptoms, the time of symptom disappearance, and the number of days in hospitalization, and the duration of infection were compared among the three groups.
Trial: NCT05074485
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravenous injection of 1 milliliter normal saline
Trial: NCT05167526
Drug: ASP8731 Matching Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral
Trial: NCT05265910
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo tablet (tablet)
Trial: NCT05367232
Drug: ICP-033 tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally, once a day, 28 days per cycle
Trial: NCT05429021
Drug: IMM-BCP-01
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Single dose of IMM-BCP-01
Trial: NCT05429021
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo matching single dose of IMM-BCP-01
Trial: NCT04640571
Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg
Trial: NCT04640571
Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg
Trial: NCT06282549
Drug: Telmisartan/Amlodipine/Chlorthalidone(Truset)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg or Telmisartan/Amlodipine/Chlorthalidone 80/5/12.5 mg or Telmisartan/Amlodipine/Chlorthalidone 80/5/25 mg
Trial: NCT05761444
Drug: Atozet 10/40 mg or 10/80 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Atozet 10/40 mg or 10/80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily
Trial: NCT05761444
Drug: Lipitor 40 mg or 80 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Lipitor 40 mg or 80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily
Trial: NCT06391034
Drug: hyperpolarized pyruvate +/-urea (13C/15N)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT04617821
Drug: mFOLFIRINOX
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.
Trial: NCT04667104
Drug: PegIFN-alpha2a
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PegIFN-alpha2a injection will be administered subcutaneously once weekly.
Trial: NCT05468346
Drug: [14C]-HEC585
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single Dose = Solution containing 200 mg/100 µCi \[14C\]-HEC585
Trial: NCT05916573
Drug: HSK16149
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single oral adminiatration, 20mg
Trial: NCT04706767
Drug: Saline infusion
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.
Trial: NCT05138146
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 60mg/m2 or 75mg/m2, IV, Day1of the1-6th treatment cycles only. Every 3 weeks a treatment cycle.
Trial: NCT05574374
Drug: DWP14012
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Potassium-competitive acid blocker
Trial: NCT05574374
Drug: DWC202202
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Clopidogrel Bisulfate
Trial: NCT05574374
Drug: DWC202203
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Proton pump inhibitor
Trial: NCT06279507
Drug: Normal Saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.9% sodium chloride 2 mL prepared in plastic syringe
Trial: NCT05536011
Drug: Comparator Products
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Exposure to at least one dose of a comparator product at any time during pregnancy
Trial: NCT05084261
Drug: BT051 200 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral BT051 200 mg once daily for 28 days.
Trial: NCT05084261
Drug: BT051 800 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral BT051 800 mg once daily for 28 days.
Trial: NCT05084261
Drug: BT051 3200 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral BT051 3200 mg once daily for 28 days.
Trial: NCT05084261
Drug: Matching Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo Matching BT051
Trial: NCT05423951
Drug: Sufentanil
RxNorm normalized name: Sufentanil
DrugBank: Sufentanil (DB00708)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.
Trial: NCT05932888
Drug: QLM3003
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）
Trial: NCT05932888
Drug: QLM3003 Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）(matching corresponding study medication)
Trial: NCT05008861
Drug: Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard dose of one of anti-PD-1/PD-L1 mAbs administered as a 1 hour infusion every 3 weeks.
Trial: NCT04421248
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In ADHD participants only: blinded, randomized, placebo-controlled, single dose, crossover on separate days separated by at least one week.
Trial: NCT04690530
Drug: Sedation
RxNorm normalized name: Tavist Non-Sedating
FDA approved: no
EMA approved: no
PMDA approved: no
Description: sedation wil be performed
Trial: NCT06410443
Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Treatment according to guideline of radiation-induced intestinal injury.
Trial: NCT05021094
Drug: Kuntai Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The instructions is pointed that each Kuntai capsule is 0.5g and the usage of Kuntai capsule is oral taking 4 capsules each time, 3 times a day, and 4 weeks is a course of treatment. The patients will taking 3 courses of treatment in this study.
Trial: NCT05021094
Drug: Femoston
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The estrogen and progesterone sequential regimen was adopted. The Femoston was contain estradiol tablets and estradiol didroxyprogesterone tablets. Red tablets (estradiol, 2 mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2 mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and three courses of treatment were taken. The patients will taking 3 courses of treatment in this study.
Trial: NCT06525519
Drug: ATLG
RxNorm normalized name: Antithymocyte Globulin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 5 mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
Trial: NCT06525519
Drug: ATLG
RxNorm normalized name: Antithymocyte Globulin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 7.5mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
Trial: NCT05323396
Drug: Antiparasitic medication
RxNorm normalized name: hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Participants in the parasite-positive group (based on positive result of either stool microscopy, stool PCR, or Strongyloides IgG) will be administered antiparasitic treatment. Antiparasitic medication administered will be targeted to treat the parasite identified. See detailed description of protocol for medication, dose, and frequency that will be given for each parasitic infection identified.~Participants with stool microscopy, stool PCR, and Strongyloides IgG all negative will not be administered treatment, thus will serve as controls.
Trial: NCT04710160
Drug: Novel fast-setting calcium silicate cement (Protooth)
RxNorm normalized name: Calcium Silicate
DrugBank: Calcium silicate (DB13829)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In form of power and liquid to be mixed together to form a paste.
Trial: NCT05396677
Drug: Acetaminophen
RxNorm normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 x 500 mg acetaminophen (one time)
Trial: NCT05677867
Drug: Formulation A (PF-07081532 20 mg plus 60 mg)
RxNorm normalized name: codeine
DrugBank: Codeine (DB00318)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Formulation A: administered as a 20 mg immediate release tablet and a 60 mg immediate release tablet
Trial: NCT05677867
Drug: Formulation B (PF-07081532 80 mg)
RxNorm normalized name: Hep B, unspecified formulation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Formulation B: administered as a 80 mg immediate release tablet
Trial: NCT05645198
Drug: Oozfix
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Directly apply carboxymetyl starch (Oozfix) 5 gram evenly at the suprapancreatic surgical bed after gastrectomy
Trial: NCT05645198
Drug: Greenplast
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Directly apply Greenplast (Aprotinin 1000kIU/mL, Thrombin 500IU/mL, Fibrinogen 95mg/mL) 4 gram evenly at the suprapancreatic surgical bed after gastrectomy
Trial: NCT06132126
Drug: LY3938577
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT06132126
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC.
Trial: NCT05302388
Drug: SIBP-R002
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SIBP-R002: injection; strength: 1, 2, 4, 8 or 12 mg; dose escalation and the first group is 1mg (intravenous infusion, 5 groups, the first group consisted of four people, and the other groups consisted of eight).
Trial: NCT05302388
Drug: Dexamethasone or Methyl prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intravenous infusion, 5mg or 1\~2mg/kg. These were administered within 30 minutes prior to infusion of the experimental drug.
Trial: NCT05302388
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The same volume of placebo as SIBP-R002: injection; strength: the same volume of placebo as SIBP-R002 of 1, 2, 4, 8 or 12 mg (intravenous infusion, 5 groups, the first group consisted of one people, and the other groups consisted of two). The rule and dose of placebo were the same as SIBP-R002.
Trial: NCT04626323
Drug: Best medical treatment
RxNorm normalized name: zinc pyrithione Medicated Shampoo [Head & Shoulders Damage Treatment]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will also receive standard of care medical therapy for DKD (ACEI or ARB + SGLT2i) and T2DM (metformin, glitazones, incretin therapy - DPP4 inhibitor and GLP-1 analogs - and insulin, if necessary).
Trial: NCT04889040
Drug: RO7496998
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 275 mg tablets
Trial: NCT04889040
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching tablets
Trial: NCT04942730
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 50 mg/kg iv x 2 days, Days +3 through +4
Trial: NCT06121115
Drug: Norepinephrine
RxNorm normalized name: Norepinephrine
DrugBank: Norepinephrine (DB00368)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Norepinephrine administered in midline catheter according to clinical routine
Trial: NCT05864261
Drug: JT1801 60ug
FDA approved: no
EMA approved: no
PMDA approved: no
Description: JT1801, 60ug, IV injection
Trial: NCT05864261
Drug: NESP 60ug
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NESP, 60ug, IV injection
Trial: NCT04698941
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20mg daily oral tablet taken.
Trial: NCT05363202
Drug: Matching Placebo inhaler
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Trial: NCT06551740
Drug: HUC2-344
FDA approved: no
EMA approved: no
PMDA approved: no
Description: per oral
Trial: NCT06551740
Drug: HUC2-344-R1, HUC2-344-R2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: per oral
Trial: NCT05516550
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive Placebo in the morning and in the evening daily during 4 weeks
Trial: NCT06475872
Drug: Crecheck Tablet 2.5 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 tablets orally once a day
Trial: NCT06475872
Drug: Crestor Tablet 5 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 tablet orally once a day
Trial: NCT05597462
Drug: Minocycline hydrochloride capsules
RxNorm normalized name: Minocycline Hydrochloride Capsules
DrugBank: Minocycline (DB01017)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks.
Trial: NCT05483634
Drug: Vaginal estrogen supplement
RxNorm normalized name: estrogens, conjugated (USP) Vaginal Cream [Premarin]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Daily vaginal estrogen supplement, then twice per week. Continue for three months.
Trial: NCT06266715
Drug: ATP Group
RxNorm normalized name: Streptococcus viridans group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.
Trial: NCT06266715
Drug: Placebo Group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cap escitalopram 10mg OD for four weeks and injection110ml NS BD for two weeks.
Trial: NCT05556005
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Starch tablets used twice daily
Trial: NCT04310423
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matched to endotoxin
Trial: NCT06382961
Drug: Sufentanil injection
RxNorm normalized name: sufentanil Injection
DrugBank: Sufentanil (DB00708)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 3 μg.kg-1 sufentanil is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour.
Trial: NCT06422039
Drug: HRS-7535（D）Tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One HRS-7535（D）Tablet is administered to healthy subjects.
Trial: NCT06422039
Drug: HRS-7535（C）Tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Two HRS-7535（C）Tablets is administered to healthy subjects.
Trial: NCT00343954
Drug: L-citrulline tablets, 1000 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT05393284
Drug: OPL-0401 Dose 1
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Pharmaceutical Form: Capsule; Route of Administration: Oral
Trial: NCT05393284
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical Form: Capsule; Route of Administration: Oral
Trial: NCT06175663
Drug: Antihypertensive medication withdrawal
RxNorm normalized name: ANTIHYPERTENSIVES
FDA approved: no
EMA approved: no
PMDA approved: no
Description: To determine if high blood pressure is caused by an overproduction of aldosterone in the adrenal gland (i.e. primary hyperaldosteronism), the plasma aldosterone/renin ratio (ARR) can be determined. Because many common hypertensive drugs are known to interfere with this ratio, patients often have to discontinue drugs prior to screening or switch to drugs that are known not to affect ARR (i.e. doxazosin, verapamil, diltiazem, hydralazine). Drugs have to be stopped for at least four weeks (for mineralocorticoid receptor antagonists) or two weeks (for diuretics, Angiotensin Converting Enzyme (ACE) inhibitors, Angiotensin Receptor Blockers (ARBs)). This often leads to a temporary increase in blood pressure. After diagnostics are completed, medication is adjusted accordingly and blood pressure levels drop again.
Trial: NCT05468203
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be randomly assigned to receive either dapagliflozin 10 mg or placebo daily while in ICU for up to 30 days
Trial: NCT05122754
Drug: B/F/TAF
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Bictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.
Trial: NCT05122754
Drug: TDF-based triple ART regimen switching to B/F/TAF
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tenofovir disoproxil fumarate was administered once daily, one tablet at a time, with or without food. After Week 24, control subjects were also switched to bictegravir/emtricitabine/tenofovir alafenamide once daily, one tablet at a time, with or without food for the later 24 weeks.
Trial: NCT04623710
Drug: ALXN2050
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4.
Trial: NCT05027997
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral matching placebo tablet
Trial: NCT04807829
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inactive placebo comparator
Trial: NCT04629144
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Both arms will have the same corticosteroid tapering scheme, with an initial dose of 30 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive:~* 30 mg/day week (W)0-W2,~* 20 mg/day W2-W4~* 15 mg/day W4-W6,~* 10 mg/day W6-W8,~* 5 mg/day W8-W10~Between W10-W12 the strategy for stopping glucocorticoids is left to the investigator's discretion.~Stopping glucocorticoid therapy at W12. At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity.