{"id":69094,"date":"2022-07-26T21:18:06","date_gmt":"2022-07-26T21:18:06","guid":{"rendered":"https:\/\/access1study.com\/about-the-study-2\/"},"modified":"2024-08-28T18:22:06","modified_gmt":"2024-08-28T18:22:06","slug":"about-the-study-2","status":"publish","type":"page","link":"https:\/\/access1study.com\/ar\/","title":{"rendered":"About the Study"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row row_height_percent=&#8221;85&#8243; back_image=&#8221;70&#8243; back_position=&#8221;center bottom&#8221; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;553705&#8243; el_class=&#8221;righttoleft&#8221;][vc_column column_width_use_pixel=&#8221;yes&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;2&#8243; style=&#8221;dark&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;162231&#8243; column_width_pixel=&#8221;700&#8243; el_class=&#8221;righttoleft&#8221;][vc_empty_space empty_h=&#8221;3&#8243;][vc_single_image media=&#8221;3641&#8243; media_width_percent=&#8221;40&#8243; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;155350&#8243;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;fontsize-695254&#8243; text_weight=&#8221;400&#8243; sub_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;179197&#8243;]The <strong>ACCESS-1<\/strong> Study[\/vc_custom_heading][vc_custom_heading heading_semantic=&#8221;p&#8221; text_weight=&#8221;700&#8243; text_height=&#8221;fontheight-121505&#8243; sub_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;127093&#8243;]A clinical study for adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) who are new to treatment* or have not recently received treatment.[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_button button_color=&#8221;color-637731&#8243; custom_typo=&#8221;yes&#8221; font_family=&#8221;font-555555&#8243; font_weight=&#8221;700&#8243; text_transform=&#8221;uppercase&#8221; letter_spacing=&#8221;fontspace-634022&#8243; border_width=&#8221;0&#8243; link=&#8221;url:%23whatis%20|title:What%20to%20Expect&#8221; button_color_type=&#8221;uncode-palette&#8221; uncode_shortcode_id=&#8221;115458&#8243; width=&#8221;244&#8243; el_class=&#8221;righttoleft&#8221;]Learn More[\/vc_button][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;3&#8243; bottom_padding=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;127407&#8243; row_name=&#8221;whatis&#8221;][vc_column column_width_use_pixel=&#8221;yes&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;166604&#8243; column_width_pixel=&#8221;1000&#8243;][vc_column_text uncode_shortcode_id=&#8221;192394&#8243;]*Treatment with a complement inhibitor[\/vc_column_text][vc_empty_space empty_h=&#8221;3&#8243;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;h1&#8243; sub_lead=&#8221;yes&#8221; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;776542&#8243;]What is the purpose of the ACCESS-1 Study?<a id=\"what-is\"><\/a>[\/vc_custom_heading][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;121895&#8243;]The purpose of this study is to learn more about the effects of an experimental combination treatment to see how well-tolerated and effective it is compared to the already approved treatment, eculizumab. Eculizumab is also known as a \u201ccomplement inhibitor.\u201d*[\/vc_column_text][vc_empty_space empty_h=&#8221;3&#8243;][vc_custom_heading sub_lead=&#8221;small&#8221; uncode_shortcode_id=&#8221;187237&#8243; subheading=&#8221;*Please note that this clinical trial will use investigational drug products, the safety and efficacy of which have not been fully evaluated by Regulatory Authorities and which have not received marketing authorization in any country.&#8221;][\/vc_custom_heading][vc_separator sep_color=&#8221;color-637731&#8243; uncode_shortcode_id=&#8221;207532&#8243; sep_color_type=&#8221;uncode-palette&#8221;][\/vc_column][\/vc_row][vc_row][vc_column column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;143776&#8243;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;h1&#8243; sub_lead=&#8221;yes&#8221; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;842768&#8243;]What are the investigational study drugs?[\/vc_custom_heading][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;352610&#8243;]The investigational study drugs work together to reduce the levels and activity of C5, a protein involved in the destruction of red blood cells in people with PNH.[\/vc_column_text][vc_empty_space empty_h=&#8221;3&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; limit_content=&#8221;&#8221; uncode_shortcode_id=&#8221;113414&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;150574&#8243;][vc_custom_heading uncode_shortcode_id=&#8221;129701&#8243; subheading=&#8221;An investigational drug called a monoclonal antibody designed to block the activity of C5. After a single infusion (first dose), Investigational Study Drug A is given as an injection under the skin.&#8221;]<\/p>\n<p class=\"p1\">Investigational Study Drug A<\/p>\n<p>[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;902317&#8243;][vc_custom_heading uncode_shortcode_id=&#8221;113533&#8243; subheading=&#8221;An investigational drug that reduces the production of C5 protein in the liver. As a result, less total C5 is made. Investigational Study Drug B is given as an injection under the skin.&#8221;]<\/p>\n<p class=\"p1\">Investigational Study Drug B<\/p>\n<p>[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;176095&#8243;][vc_custom_heading uncode_shortcode_id=&#8221;192935&#8243; subheading=&#8221;Eculizumab is an approved treatment for PNH in some countries. Eculizumab is a monoclonal antibody designed to block the activity of C5 and is given by regular infusions into a vein.&#8221;]<\/p>\n<p class=\"p1\">Eculizumab<\/p>\n<p>[\/vc_custom_heading][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;2&#8243;][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;118158&#8243;][vc_column width=&#8221;1\/1&#8243;][vc_single_image media=&#8221;28&#8243; media_width_percent=&#8221;100&#8243; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;209098&#8243;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;1&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;520349&#8243;][vc_column column_width_use_pixel=&#8221;yes&#8221; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;207080&#8243; column_width_pixel=&#8221;1000&#8243;][vc_empty_space empty_h=&#8221;3&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;2&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; limit_content=&#8221;&#8221; uncode_shortcode_id=&#8221;132582&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; back_image=&#8221;82&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;150003&#8243; back_size=&#8221;60%&#8221;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;h1&#8243; uncode_shortcode_id=&#8221;515983&#8243; el_class=&#8221;header-rotate&#8221;]Who can participate in this study?[\/vc_custom_heading][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243;][vc_custom_heading heading_semantic=&#8221;h3&#8243; text_size=&#8221;h3&#8243; uncode_shortcode_id=&#8221;745528&#8243;]This study is for adults 18 years of age and older who:[\/vc_custom_heading][uncode_list uncode_shortcode_id=&#8221;144254&#8243;]<\/p>\n<ul>\n<li>Have a confirmed diagnosis of PNH<\/li>\n<li>Have active disease (\u22651 sign or symptom of PNH or history of blood transfusion due to PNH within the last 3 months)<\/li>\n<li>Have not been treated with a complement inhibitor (for example, ravulizumab or eculizumab)<\/li>\n<\/ul>\n<p>[\/uncode_list][vc_column_text uncode_shortcode_id=&#8221;149237&#8243;]<em>Note: Other study inclusion\/exclusion criteria apply<\/em>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_right&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;920632&#8243;][vc_custom_heading uncode_shortcode_id=&#8221;416201&#8243;]Does this sound like you?[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;135344&#8243;][vc_button button_color=&#8221;color-637731&#8243; border_width=&#8221;0&#8243; link=&#8221;url:%23cta&#8221; button_color_type=&#8221;uncode-palette&#8221; uncode_shortcode_id=&#8221;364469&#8243; width=&#8221;244&#8243;]Contact Us[\/vc_button][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;3&#8243;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;1&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;252701&#8243; back_color_type=&#8221;uncode-solid&#8221; row_name=&#8221;study-sites&#8221; back_color_solid=&#8221;#c5e7f6&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;168789&#8243;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;h1&#8243; uncode_shortcode_id=&#8221;535215&#8243;]Find a study site[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;191527&#8243;]            <div class=\"store-info-container no-map\">\r\n                <div class=\"store-locations\">\r\n                    <div class=\"store-locations-search OneLinkTx\">\r\n                        <form role=\"search\" class=\"store-search-form\">\r\n                            <label for=\"search-text\"><\/label>\r\n                            <input type=\"text\" value name=\"search-text\" id=\"search-text\"\r\n                                   placeholder=\"Enter a location\">\r\n                            <input type=\"image\" id=\"search-btn\" alt=\"Search\" src=\"https:\/\/access1study.com\/wp-content\/plugins\/jh-wp-site-listing-main\/images\/icon-arrow-right.svg\">\r\n                            <input type=\"hidden\" id=\"place_lat\" value=\"\">\r\n                            <input type=\"hidden\" id=\"place_lng\" value=\"\">\r\n                            <input type=\"hidden\" id=\"show_map\" name=\"show_map\"\r\n                                   value=\"no\">\r\n\t\t\t\t\t\t\t                            <input type=\"hidden\" id=\"language_code\" value=\"ar\">\r\n                        <\/form>\r\n\t\t\t\t\t\t                    <\/div>\r\n                    <h5 class=\"store-locations-result-info OneLinkTx\">\r\n\t\t\t\t\t\tShowing                        <span id=\"found-results\"> 0<\/span> Results Near You                    <\/h5>\r\n\t\t\t\t\t                        <div class=\"store-locations-list-nav\">\r\n                            <h4>Study Site<\/h4>\r\n                            <h4>Study Provider<\/h4>\r\n                            <h4>Address<\/h4>\r\n                            <h4>Contact<\/h4>\r\n                        <\/div>\r\n\t\t\t\t\t                    <div class=\"store-locations-list\" id=\"ajax_results_wrapper\">\r\n                    <\/div>\r\n                <\/div>\r\n\t\t\t\t            <\/div>\r\n\t\t\t[\/vc_column_text][vc_empty_space empty_h=&#8221;2&#8243;][vc_separator sep_color=&#8221;color-637731&#8243; 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