natgillin/translations-raw huggingface dataset:
Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).
Študije s telmisartanom na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Study
Preskušanje
Study (2004)
študija (2004)
Study (2006)
študija (2006)
STUDY *
ŠTUDIJA
Study 0122 (ELECTRON-2)
Študija 0122 (ELECTRON-2)
Study 020
Študija 020
Study 020 enrolled
V študiji 020 je sodelovalo
Study 025 was a 9 month, open-label study in 12 adult (≥18 years) patients who were naïve to ERT (defined as having not been treated with ERT for at least 12 months prior to study entry).
Študija 025 je bila 9-mesečna odprta študija pri 12 odraslih bolnikih (starih ≥ 18 let), ki predhodno niso prejemali NEZ (opredeljeno kot to, da niso prejemali NEZ vsaj 12 mesecev pred vstopom v študijo).
Study 02507 was a randomized, double-blind, placebo-controlled, multicenter clinical study in 40 patients with GD1.
Študija 02507 je bila randomizirana, dvojno slepa, s placebom nadzorovana, multicentrična klinična študija pri 40 bolnikih z GD1.
Study 02607 was a randomized, open-label, active-controlled, non-inferiority, multicenter clinical study in 159 patients previously stabilised with ERT.
Študija 02607 je bila randomizirana, odprta, z aktivno učinkovino nadzorovana, multicentrična klinična študija enakovrednih skupin pri 159 bolnikih, ki so predhodno dosegli stabilno stanje z nadomestnim encimskim zdravljenjem (ERT).
Study 034 was a 12-month, open-label safety study in 40 patients aged 2 years and older who had been receiving treatment with imiglucerase at doses ranging from 15 to 60 Units/kg for a minimum of 30 consecutive months.
Študija 034 je bila 12-mesečna odprta študija varnosti pri 40 bolnikih, starih 2 leti in več, ki so prejemali imiglucerazo v odmerkih od 15 do 60 enot/kg najmanj 30 mesecev zapored.
Study 045 is a randomised, multicenter trial comparing REYATAZ/ritonavir (300/100 mg once daily) and REYATAZ/saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
REYATAZ/ritonavir (300/100 mg enkrat na dan) in zdravilo REYATAZ/sakvinavir (400/1.200 mg enkrat na dan) z lopinavirjem + ritonavirjem (400/100 mg v fiksni kombinaciji v odmerku dvakrat na dan), vse v kombinaciji s tenofovirjem (glejte poglavji 4.5 in 4.8) in enim NRTI-jem pri bolnikih z virološko neuspešnim zdravljenjem z eno ali več predhodnimi shemami, ki so obsegale vsaj en zaviralec proteaz, NRTI in NNRTI.
Study 045 is a randomised, multicenter trial comparing REYATAZ/ritonavir (300/100 mg once daily) and REYATAZ/saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil fumarate (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
REYATAZ/ritonavir (300/100 mg enkrat na dan) in zdravilo REYATAZ/sakvinavir (400/1.200 mg enkrat na dan) z lopinavirjem + ritonavirjem (400/100 mg v fiksni kombinaciji v odmerku dvakrat na dan), vse v kombinaciji z dizoproksiltenofovirat fumaratom (glejte poglavji 4.5 in 4.8) in enim NRTI- jem pri bolnikih z virološko neuspešnim zdravljenjem z eno ali več predhodnimi shemami, ki so obsegale vsaj en zaviralec proteaz, NRTI in NNRTI.
Study 0501 evaluated 2 different doses of fenofibrate-simvastatin combination compared to simvastatin 40 mg for a 24 week double-blind period.
V študiji 0501 so v 24-tedenskem dvojno slepem obdobju vrednotili dva različna odmerka kombinacije fenofibrata in simvastatina v primerjavi s simvastatinom 40 mg.
Study 1
1. študija
Study 1
n 1
Study 1 (IBS 3001)
Študija 1 (IBS 3001)
Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4 % (8/194) of patients receiving ribavirin in combination with peginterferon alfa-2b.
V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm3 pri 4 % (8/194) bolnikov in zmanjšanje števila trombocitov pod 50.000/mm3 pri 4 % (8/194) bolnikov, ki so prejemali ribavirin v kombinaciji s peginterferonom alfa-2b.
Study 1 (TID, QID)1
Študija 1 (TID, QID)1
Study 1 + Study 2
Študija 1 + študija 2
Study 1 and 2: Phase 3 studies in renal transplant recipients
Študija 1 in 2: Študiji 3. faze pri bolnikih s presajeno ledvico
Study 1 breast cancer
Študija 1: rak dojke
Study 1 evaluated 161 patients who were 12 years of age or older; 122 (75.8%) of patients had the F508del mutation in the second allele.
V študiji 1 so ovrednotili 161 bolnikov, ki so bili stari najmanj 12 let; 122 (75,8 %) bolnikov je imelo mutacijo F508del na drugem alelu.
Study 1 included an open-label phase, in which patients themselves elected to enrol.
Študija 1 je zajemala odprto fazo, v kateri so se bolniki sami odločili za sodelovanje.
Study 1 provided the pivotal data for the indication for Empliciti in combination with lenalidomide and dexamethasone.
Ključni podatki za indikacijo uporabe zdravila Empliciti v kombinaciji z lenalidomidom in deksametazonom so bili pridobljeni v študiji 1.
Study 1 Study 2
Študija 1 Študija 2
Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Študija 1 je bila študija 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10 % površine telesa.
Study 1 was a Phase 2 study in patients with active, but clinically stable, plaque psoriasis involving  10% of the body surface area who were  18 years old.
Študija 1 je bila študija 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10 % površine telesa.
Study 1*
Študija 1
Study 1, 6 index lesions; Study 2, up to 8 index lesions
Študija 1, 6 indeksnih lezij; študija 2, do 8 indeksnih lezij
Study 1001 N=53a
Študija 1001
Study 101-08/99 enrolled 64 subjects with previously untreated CLL, including 5 subjects with small lymphocytic lymphoma (SLL).
V študijo 101-08/99 je bilo vključenih 64 oseb s predhodno nezdravljenim KLL, vključno s 5 osebami z limfomom majhnih limfocitov (SLL, small lymphocytic lymphoma).
Study 106 and Study 107
Študija 106 in študija 107
Study 110 was a phase II randomised, double-blind, placebo-controlled study conducted in patients with chronic genotype 1 HCV/HIV co-infection who were treatment-naïve for hepatitis C. Patients were either not on antiretroviral therapy (CD4 count ≥ 500 cells/mm3), or had stable controlled HIV (HIV RNA < 50 copies/ml, CD4 count ≥ 300 cells/mm3) being treated with efavirenz or atazanavir/ritonavir in combination with tenofovir disoproxil fumarate and emtricitabine or lamivudine.
Randomizirana, dvojno slepa in s placebom nadzorovana študija faze II pri bolnikih s kroničnim HCV genotipa 1, sočasno okuženih s HIV, ki še niso prejemali zdravil proti hepatitisu C. Bolniki niso prejemali protiretrovirusnega zdravljenja (število celic CD4 ≥ 500 celic/mm3) ali so imeli stabilno, nadzorovano okužbo s HIV (< 50 kopij RNK HIV/ml, število celic CD4 ≥ 300 celic/mm3) in so se zdravili z efavirenzom ali s shemo atazanavir/ritonavir v kombinaciji s dizoproksiltenofovirat fumaratom in emtricitabinom ali lamivudinom.
Study 111 (ILLUMINATE)
Študija 111 (ILLUMINATE)
Study 138 is an international randomised, open-label, multicenter, prospective trial of treatment naïve patients comparing REYATAZ/ritonavir (300 mg/100 mg once daily) to lopinavir/ritonavir (400 mg/100 mg twice daily), each in combination with fixed dose tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg tablets once daily).
Študija 138 je mednarodno, randomizirano, odprto, multicentrično, prospektivno preskušanje, ki je pri predhodno še nezdravljenih bolnikih primerjalo uporabo zdravila REYATAZ/ritonavirja (300 mg/100 mg enkrat na dan) z uporabo lopinavirja/ritonavirja (400 mg/100 mg dvakrat na dan), oboje v kombinaciji s fiksnimi odmerki dizoproksiltenofovirat fumarata/emtricitabina (300 mg/200 mg tablete enkrat na dan).
Study 1: living and standard criteria deceased donors
Študija 1: živi ali umrli darovalci (standardni kriteriji za darovalca)
Study 1: Recipients of Living Donor and Standard Criteria Deceased Donor Kidneys
Študija 1: Prejemniki ledvice živega ali umrlega darovalca po standardnih kriterijih za darovani organ
Study 2
2 x/teden
Study 2
2 x/viku
Study 2
n 2
Study 2 (BD)2
Študija 2 (BD)2
Study 2 (n=1023)
študija 2 (n = 1.023)
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co- infected with HIV.
Študija 2 (P02080) je bila randomizirana, enocentrična študija, v katero so vključili 95 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi tudi z virusom HIV.
Study 2 shows that 37% of the patients treated with linaclotide compared with 19% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 55% of the patients treated with linaclotide compared with 42% of the patients treated with placebo showed response to abdominal pain/discomfort (p=0.0002).
V študiji 2 je bila stopnja odziva olajšanja sindrom razdražljivega črevesja dosežena pri 37 % bolnikov, zdravljenih z linaklotidom, v primerjavi z 19 % bolnikov, zdravljenih s placebom (p < 0,0001), odziv olajšanja abdominalne bolečine/nelagodja pa je doseglo 55 % bolnikov, zdravljenih z linaklotidom, v primerjavi z 42 % bolnikov, zdravljenih s placebom (p=0,0002).
Study 2**
Študija 2
Study 205 (n=396; n=303)
Študija 205 (n = 396, n = 303)
Study 206207-010
Študija 206207-010
Study 206207-011
Študija 206207-011
Study 2301: Vildagliptin 50 mg twice daily (N=90)
študija 2301: vildagliptin 50 mg dvakrat dnevno (N=90)
Study 2384: Vildagliptin 50 mg twice daily (N=79)
študija 2384: vildagliptin 50 mg dvakrat dnevno (N=79)
Study 2: Recipients of Extended Criteria Donor Kidneys
Študija 2: Prejemniki ledvice po razširjenih kriterijih za darovani organ
Study 3
3. študija
Study 3 (phase 2 study CAMMS223) evaluated the safety and efficacy of LEMTRADA in patients with RRMS over the course of 5 years.
V študiji 3 (študija 2. faze CAMMS223) so ocenjevali varnost in učinkovitost zdravila LEMTRADA pri bolnikih z RRMS v obdobju 5 let.
Study 3 was a single arm study of 30 patients with relapsed or refractory low-grade, follicular, or transformed B-cell NHL who had mild thrombocytopenia (platelet count 100,000 to 149,000 cells/mm3).
Študija 3 je imela en krak, v katerem je bilo 30 bolnikov z relapsnim ali neodzivnim nizkostopenjskim folikularnim NHL ali z NHL s transformacijo celic B, ki so imeli blago trombocitopenijo (število trombocitov: 100.000 – 149.000 celic/mm3).
Study 3*
Študija 3
Study 301 (n=305; n=256)
Študija 301 (n = 305, n = 256)
Study 301 (patients who had received prior chemotherapy)
Študija 301 (bolniki, ki so že prejeli kemoterapijo)
Study 301 - Overall Survival (ITT Population)
Študija 301 – celokupno preživetje (populacija z namenom zdravljenja)
Study 301 enrolled patients who had received prior docetaxel.
V študijo 301 so bili vključeni bolniki, ki predhodno prejemali docetaksel.
Study 302 (chemotherapy naïve patients)
Študija 302 (bolniki, ki še niso prejeli kemoterapije)
Study 302 (n=538; n=471)
Študija 302 (n = 538, n = 471)
Study 305 Updated Overall Survival ITT Population
Študija 305 – posodobljeno celokupno preživetje populacije z namenom zdravljenja
Study 309 - Overall Survival in the Liposarcoma Subgroup
Študija 309 – celokupno preživetje v podskupini liposarkom
Study 309 Leiomyosarcoma Subgroup
Študija 309 podskupina leiomiosarkom
Study 309 – Progression Free Survival in the Liposarcoma Subgroup
Študija 309 – preživetje brez napredovanja bolezni v podskupini liposarkom
Study 316
Študija 316
Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Študija 316 je bila randomizirano, dvojno slepo preskušanje s peroralno suspenzijo posakonazola (200 mg trikrat na dan) v primerjavi s kapsulami flukonazola (400 mg enkrat na dan) pri bolnikih po alogenski transplantaciji hematopoetskih matičnih celic z reakcijo presadka proti gostitelju (GVHD - graft-versus-host disease).
Study 3a
Študija 3a
Study 4
4. študija
Study 4 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone.
Študija 4 je zajela 37 odraslih bolnikov s histološko potrjenim inoperabilnim ali recidivnim gigantocelularnim kostnim tumorjem.
Study 5 enrolled 507 adult or skeletally mature adolescents with giant cell tumour of bone and evidence of measurable active disease.
Študija 5 je zajela 507 odraslih ali skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem in znaki merljive aktivne bolezni.
Study 5615 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole tablet.
Študija 5615 je bila neprimerjalna, multicentrična študija za oceno farmakokinetičnih lastnosti, varnosti in prenašanja tablet posakonazola.
Study 6: study in patients with CF with an R117H mutation in the CFTR gene
Študija 3: študija pri bolnikih s CF z mutacijo F508del na genu CFTR
Study 735
735
Study A ceritinib 750 mg
študija A ceritinib 750 mg
Study A was a phase 1 study which included a dose-escalation phase and an expansion phase, at the recommended dose of 750 mg.
Študija A je bila študija faze 1, ki je obsegala fazo zviševanja odmerka (dose escalation phase) in fazo zdravljenja z najvišjim odmerkom (expansion phase) in sicer s priporočenim odmerkom 750 mg.
Study A4001029 was an exploratory study in patients infected with dual/mixed or CXCR4 tropic HIV- 1 with a similar design as the studies MOTIVATE 1 and MOTIVATE 2.
Študija A4001029 je bila eksplorativna študija pri bolnikih, okuženih z dualno/mešano-tropnim ali CXCR4-tropnim HIV-1; načrt študije je bil podoben kot načrt študij MOTIVATE 1 in MOTIVATE 2.
Study AAU02
Dan;
Study AC-052-356 [BREATHE-3]) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with pulmonary arterial hypertension (PAH) who were dosed on the basis of body weight with 2 mg/kg twice daily.
V študiji AC-052-356 [BREATHE-3]) so ocenjevali farmakokinetiko enkratnega in večkratnih peroralnih odmerkov bosentana v obliki filmsko obloženih tablet pri 19 otrocih, starih od 3 do 15 let, s pljučno arterijsko hipertenzijo (PAH), katerih odmerke so določili na podlagi telesne mase in so znašali 2 mg/kg dvakrat dnevno.
Study AC-052-516: Disease characteristics and outcomes of pulmonary arterial hypertension in children and adolescents in real-world clinical settings to collect further data on long-term safety and outcomes in paediatric patients with PAH (Systematic review of prospective observational registries)
Študija AC-052-516: Značilnosti in izidi bolezni za pljučno arterijsko hipertenzijo pri otrocih in mladostnikih v realnih kliničnih okoliščinah za zbiranje nadaljnjih podatkov o dolgoročni varnosti in izidih pri pediatričnih bolnikih s PAH (sistematski pregled prospektivnih opazovalnih registrov)
Study ACTG 364
Študija ACTG
Study ACTG 364
Študija ACTG 364
Study ADE04
Dan;
Study ADE10
Študija ADE10
Study AI266073 was a 48-week open-label randomised clinical study in HIV infected patients comparing the efficacy of Atripla to antiretroviral therapy consisting of at least two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs) with a protease inhibitor or non-nucleoside reverse transcriptase inhibitor; however not a regimen containing all Atripla components (efavirenz, emtricitabine and tenofovir disoproxil fumarate).
Pri bolnikih, okuženih z virusom HIV, je bila izvedena 48-tedenska odprta randomizirana klinična študija AI266073, v kateri so učinkovitost zdravila Atripla primerjali z učinkovitostjo protiretrovirusnega zdravljenja z vsaj dvema nukleozidnima ali nukleotidnima zaviralcema reverzne transkriptaze (NRTI) z zaviralcem proteaze ali nenukleozidnim zaviralcem reverzne transkriptaze, vendar pa ne z režimom, ki bi vključeval vse tri učinkovine zdravila Atripla (efavirenz, emtricitabin in dizoproksiltenofovirijev fumarat).
Study AI444010
Konec zdravljenja
Study AI444042
Študija AI444042 Študija AI444010
Study AMD3100-3101 efficacy results - CD34+ cell mobilisation in non-Hodgkin’s lymphoma patients
Rezultati učinkovitosti v študiji AMD3100-3101 – Mobilizacija celic CD34+pri bolnikih z ne-Hodgkinovim limfomom
Study AMD3100-3101 – Proportion of patients who achieved ≥ 5 x 106 CD34+ cells/kg by apheresis day in non-Hodgkin’s lymphoma patients
Študija AMD3100-3101 – Delež bolnikov, ki so dosegli ≥ 5 x 106 celic CD34+/kg na dan afereze, pri bolnikih z ne-Hodgkinovim limfomom
Study AMD3100-3102 efficacy results – CD34+ cell mobilisation in multiple myeloma patients
Rezultati učinkovitosti v študiji AMD3100-3102 – Mobilizacija celic CD34+ pri bolnikih z multiplim mielomom
Study AMD3100-3102 – Proportion of patients who achieved ≥ 6 x 106 CD34+ cells/kg by apheresis day in multiple myeloma patients
Študija AMD3100-3102 – Delež bolnikov, ki so dosegli ≥ 6 x 106 CD34+ celic/kg na dan afereze, pri bolnikih z multiplim mielomom
Study arms
Skupine v študiji
Study Arms and Duration (Number of Subjects Treated)
Študijske skupine in trajanje (število zdravljenih preiskovancev)
Study AVF3694g was a Phase III, multicentre, randomised, placebo-controlled trial designed to evaluate the efficacy and safety of Avastin in combination with chemotherapy compared to chemotherapy plus placebo as first-line treatment for patients with HER2-negative metastatic or locally recurrent breast cancer.
AVF3694g je bilo multicentrično, randomizirano, s placebom primerjano preskušanje faze III, ki je proučevalo učinkovitost in varnost zdravila Avastin v kombinaciji s kemoterapijo v primerjavi s kemoterapijo in placebom, v prvi liniji zdravljenja bolnikov s HER2 negativnim metastatskim ali lokalno recidivnim rakom dojk.
Study B ceritinib 750 mg
študija B ceritinib 750 mg
Study B involved 140 patients who had been previously treated with 1-3 lines of cytotoxic chemotherapy followed by treatment with crizotinib, and who had then progressed on crizotinib.
V študijo B je bilo vključenih 140 bolnikov, ki so predhodno prejeli 1 do 3 citotoksične kemoterapevtike in nato še zdravljenje s krizotinibom, ob katerem je prišlo do napredovanja bolezni.
Study B was a phase 2 study to evaluate the efficacy and safety of 750 mg ceritinib in patients with locally advanced or metastatic ALK-positive NSCLC.
Študija B je bila študija faze 2 za ovrednotenje učinkovitosti in varnosti ceritiniba v odmerku 750 mg pri bolnikih z lokalno napredovalim ali metastatskim ALK-pozitivnim nedrobnoceličnim pljučnim rakom.
Study BCIRG 006 study was designed to investigate combining Herceptin treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery.
Preskušanje BCIRG 006 je bilo zasnovano za proučevanje kombinacije zdravljenja z zdravilom Herceptin in docetakselom, bodisi po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC) bodisi v kombinaciji z docetakselom in karboplatinom pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji.
Study BO16348 was designed to compare one and two years of three-weekly Herceptin treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Študija BO16348 je bila zasnovana za primerjavo enoletnega in dvoletnega zdravljenja z zdravilom Herceptin (odmerjanjem na 3 tedne) z opazovanjem bolnikov z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji, standardni kemoterapiji in radioterapiji (kar so uporabili).
Study BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus Herceptin intravenous formulation based on co-primary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively).
Študijo BO22227 so zasnovali, da bi dokazali neinferiornost subkutane oblike zdravila Herceptin v primerjavi z intravensko obliko zdravila Herceptin glede na soprimarni farmakokinetični končni cilj (Cthrough trastuzumaba pred odmerkom 8. cikla) in končni cilj, povezan z učinkovitostjo (delež pCR ob definitivni operaciji).
Study C08-003A/B was a prospective, controlled, open-label study which accrued patients with longer term aHUS without apparent evidence of clinical thrombotic microangiopathy manifestations and receiving chronic PE/PI (≥1 PE/PI treatment every two weeks and no more than 3 PE/PI treatments/week for at least 8 weeks before the first dose).
Študija C08-003A/B je bila prospektivna, kontrolirana, odprta študija, ki je vključevala bolnike z dolgotrajnim aHUS brez očitnih znakov klinično izražene trombotične mikroangiopatije, ki so prejemali kronično PE/PI (≥1 PE/PI terapija vsake dva tedna in ne več kot 3 terapije PE/PI na teden vsaj 8 tednov pred prvim odmerkom).
Study C211 was a randomised, open-label, Phase 3 study conducted in treatment-naïve patients who were randomised to one of two treatment groups: INCIVO 750 mg every 8 hours [T12(q8h)/PR] or INCIVO 1,125 mg twice daily [T12(b.i.d.)/PR] in combination with peginterferon alfa-2a and ribavirin.
Študija C211 je bila randomizirana, odprta študija faze III pri še nezdravljenih bolnikih, ki so bili naključno razdeljeni v eno izmed dveh skupin: INCIVO 750 mg na 8 ur [T12(q8h)/PR] ali INCIVO mg dvakrat na dan [T12(b.i.d.)/PR] v kombinaciji s peginterferonom alfa-2a in ribavirinom.
Study C2305, patients who had no prior medical treatment
Študija C2305, bolniki, ki predhodno še niso bili zdravljeni
Study C2402 was a phase III, multicentre, randomised, parallel-group, three-arm study of double-blind pasireotide intramuscular use 40 mg and 60 mg versus open-label octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg in patients with inadequately controlled acromegaly.
Študija C2402 je bila multicentrična, randomizirana študija faze III s tremi vzporednimi skupinami z dvojno slepim zdravljenjem s pasireotidom za intramuskularno uporabo v odmerku 40 mg oziroma 60 mg v primerjavi z odprtim zdravljenjem z oktreotidom za intramuskularno uporabo v odmerku 30 mg ali z lanreotidom za globoko subkutano injiciranje v odmerku 120 mg pri bolnikih, pri katerih akromegalija ni bila ustrezno urejena.
Study C2402, inadequately controlled patients
Študija C2402, bolniki, pri katerih bolezen ni bila ustrezno urejena
Study CAC-002-01, (An open-label, single-centre, nonrandomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis), was the continuation of study CAC-91- 10-10 and started on 1 Jan 2010.
Študija CAC-002-01 (Odprta, enocentrična, nerandomizirana nadaljevalna študija kapsul holne kisline pri bolnikih s prirojenimi okvarami sinteze žolčnih kislin – An open-label, single-centre, nonrandomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis) je bila nadaljevanje študije CAC-91-10-10 in se je začela 1. januarja 2010.